Trial Outcomes & Findings for A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease (NCT NCT05182840)

Last Updated: 2024-10-22

Results Overview

The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

714 participants

Primary outcome timeframe

The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Results posted on

2024-10-22

Participant Flow

The trial included two randomisations, R1 and R2. At first randomisation R1, patients were 1:1 randomised to a run-in period of 8 weeks and received 10 mg empagliflozin or placebo matching empagliflozin. The run-in period was followed by randomisation R2 at which patients were 1:1:1:1 randomized to a treatment period of 14 weeks to receive one of three doses of BI 690517 or placebo matching BI 690517 in combination with the background medication assigned in the randomized run-in period.

2 patients of the arm "Run-in period: Placebo to empagliflozin 10 mg" who did not complete the Run-in period (RP) were mistakenly randomized to the treatment period (TP) but were not treated during the TP with BI 690517 or placebo to BI 690517.

Participant milestones

Participant milestones
Measure	Run-in Period: 10 mg Empagliflozin Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.	Run-in Period: Placebo to Empagliflozin 10 mg Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.	Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Run-in Period STARTED	356	358	0	0	0	0	0	0	0	0
Run-in Period Treated With Empagliflozin 10 mg or Placebo Matching Empagliflozin 10 mg	356	357	0	0	0	0	0	0	0	0
Run-in Period COMPLETED	332	330	0	0	0	0	0	0	0	0
Run-in Period NOT COMPLETED	24	28	0	0	0	0	0	0	0	0
Completed RP and Randomized to TP STARTED	332	330	0	0	0	0	0	0	0	0
Completed RP and Randomized to TP COMPLETED	298	286	0	0	0	0	0	0	0	0
Completed RP and Randomized to TP NOT COMPLETED	34	44	0	0	0	0	0	0	0	0
Patients Starting the Treatment Period STARTED	298	288	0	0	0	0	0	0	0	0
Patients Starting the Treatment Period Did Not Complete the run-in Period and Was Randomized to Treatment Period	0	2	0	0	0	0	0	0	0	0
Patients Starting the Treatment Period Completed run-in Period and Randomized to Treatment Period	298	286	0	0	0	0	0	0	0	0
Patients Starting the Treatment Period COMPLETED	298	288	0	0	0	0	0	0	0	0
Patients Starting the Treatment Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
Treatment Period STARTED	0	0	76	74	74	74	71	72	72	73
Treatment Period Treated With BI 690517 or Placebo Matching BI 690517	0	0	76	73	74	74	70	71	72	73
Treatment Period COMPLETED	0	0	63	50	55	58	61	54	48	66
Treatment Period NOT COMPLETED	0	0	13	24	19	16	10	18	24	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in Period: 10 mg Empagliflozin Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.	Run-in Period: Placebo to Empagliflozin 10 mg Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.	Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Run-in Period Not treated	0	1	0	0	0	0	0	0	0	0
Run-in Period Other reason but not sponsor termination	14	18	0	0	0	0	0	0	0	0
Run-in Period No reason available	2	2	0	0	0	0	0	0	0	0
Run-in Period Burden of study procedures	2	2	0	0	0	0	0	0	0	0
Run-in Period Change of residence	1	0	0	0	0	0	0	0	0	0
Run-in Period Adverse Event	5	5	0	0	0	0	0	0	0	0
Completed RP and Randomized to TP Did not meet additional inclusion/exclusion criteria for Treatment Period	34	44	0	0	0	0	0	0	0	0
Treatment Period Reason missing	0	0	1	0	0	0	0	0	0	0
Treatment Period Other but not sponsor termination	0	0	8	6	6	7	5	8	7	2
Treatment Period Protocol deviation	0	0	0	0	0	0	0	0	1	0
Treatment Period No reason available	0	0	0	1	0	2	0	1	0	0
Treatment Period Burden of study procedures	0	0	0	0	1	0	0	0	0	0
Treatment Period Change of residence	0	0	0	0	0	1	0	0	0	0
Treatment Period Adverse Event	0	0	4	16	12	6	4	8	16	5
Treatment Period Not treated with study drug	0	0	0	1	0	0	1	1	0	0

Baseline Characteristics

Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 n=76 Participants This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 n=74 Participants This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 n=74 Participants This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 n=74 Participants This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 n=71 Participants This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 n=72 Participants This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 n=72 Participants This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 n=73 Participants This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Total n=586 Participants Total of all reporting groups
Age, Continuous	65.4 Years STANDARD_DEVIATION 11.2 • n=76 Participants	64.4 Years STANDARD_DEVIATION 12.3 • n=74 Participants	61.8 Years STANDARD_DEVIATION 12.2 • n=74 Participants	63.4 Years STANDARD_DEVIATION 10.3 • n=74 Participants	64.4 Years STANDARD_DEVIATION 11.8 • n=71 Participants	64.8 Years STANDARD_DEVIATION 9.9 • n=72 Participants	64.3 Years STANDARD_DEVIATION 10.7 • n=72 Participants	62.3 Years STANDARD_DEVIATION 11.4 • n=73 Participants	63.8 Years STANDARD_DEVIATION 11.3 • n=586 Participants
Sex: Female, Male Female	27 Participants n=76 Participants	30 Participants n=74 Participants	20 Participants n=74 Participants	31 Participants n=74 Participants	20 Participants n=71 Participants	23 Participants n=72 Participants	27 Participants n=72 Participants	18 Participants n=73 Participants	196 Participants n=586 Participants
Sex: Female, Male Male	49 Participants n=76 Participants	44 Participants n=74 Participants	54 Participants n=74 Participants	43 Participants n=74 Participants	51 Participants n=71 Participants	49 Participants n=72 Participants	45 Participants n=72 Participants	55 Participants n=73 Participants	390 Participants n=586 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=76 Participants	21 Participants n=74 Participants	12 Participants n=74 Participants	20 Participants n=74 Participants	22 Participants n=71 Participants	21 Participants n=72 Participants	18 Participants n=72 Participants	24 Participants n=73 Participants	163 Participants n=586 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=76 Participants	53 Participants n=74 Participants	62 Participants n=74 Participants	54 Participants n=74 Participants	49 Participants n=71 Participants	51 Participants n=72 Participants	54 Participants n=72 Participants	49 Participants n=73 Participants	423 Participants n=586 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=76 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=72 Participants	0 Participants n=73 Participants	0 Participants n=586 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=76 Participants	2 Participants n=74 Participants	1 Participants n=74 Participants	2 Participants n=74 Participants	2 Participants n=71 Participants	2 Participants n=72 Participants	3 Participants n=72 Participants	1 Participants n=73 Participants	13 Participants n=586 Participants
Race (NIH/OMB) Asian	17 Participants n=76 Participants	27 Participants n=74 Participants	20 Participants n=74 Participants	19 Participants n=74 Participants	23 Participants n=71 Participants	15 Participants n=72 Participants	19 Participants n=72 Participants	16 Participants n=73 Participants	156 Participants n=586 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=76 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=72 Participants	1 Participants n=73 Participants	1 Participants n=586 Participants
Race (NIH/OMB) Black or African American	9 Participants n=76 Participants	6 Participants n=74 Participants	7 Participants n=74 Participants	10 Participants n=74 Participants	3 Participants n=71 Participants	9 Participants n=72 Participants	9 Participants n=72 Participants	10 Participants n=73 Participants	63 Participants n=586 Participants
Race (NIH/OMB) White	49 Participants n=76 Participants	35 Participants n=74 Participants	45 Participants n=74 Participants	42 Participants n=74 Participants	42 Participants n=71 Participants	45 Participants n=72 Participants	40 Participants n=72 Participants	44 Participants n=73 Participants	342 Participants n=586 Participants
Race (NIH/OMB) More than one race	1 Participants n=76 Participants	4 Participants n=74 Participants	1 Participants n=74 Participants	1 Participants n=74 Participants	1 Participants n=71 Participants	1 Participants n=72 Participants	1 Participants n=72 Participants	1 Participants n=73 Participants	11 Participants n=586 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=76 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=74 Participants	0 Participants n=71 Participants	0 Participants n=72 Participants	0 Participants n=72 Participants	0 Participants n=73 Participants	0 Participants n=586 Participants
Urine Albumin Creatinine Ratio (UACR) at baseline	780.3 milligram/gram STANDARD_DEVIATION 828.8 • n=76 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	740.8 milligram/gram STANDARD_DEVIATION 915.0 • n=73 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	695.4 milligram/gram STANDARD_DEVIATION 748.0 • n=74 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	801.4 milligram/gram STANDARD_DEVIATION 1132.3 • n=74 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	934.0 milligram/gram STANDARD_DEVIATION 1363.6 • n=70 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	646.2 milligram/gram STANDARD_DEVIATION 685.2 • n=71 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	785.0 milligram/gram STANDARD_DEVIATION 885.7 • n=72 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	684.4 milligram/gram STANDARD_DEVIATION 715.1 • n=73 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.	757.9 milligram/gram STANDARD_DEVIATION 930.5 • n=583 Participants • Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not. Three patients in the RS had missing baseline values for UACR.

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients	-0.235 log (milligram/gram) Interval -0.355 to -0.114	-0.553 log (milligram/gram) Interval -0.681 to -0.425	-0.487 log (milligram/gram) Interval -0.616 to -0.357	-0.066 log (milligram/gram) Interval -0.184 to 0.051

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients	-20.9 percent change of FMV UACR Interval -29.9 to -10.8	-42.5 percent change of FMV UACR Interval -49.4 to -34.6	-38.5 percent change of FMV UACR Interval -46.0 to -30.0	-6.4 percent change of FMV UACR Interval -16.8 to 5.3

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.

The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin	-0.254 log (milligram/gram) Interval -0.441 to -0.068	-0.496 log (milligram/gram) Interval -0.693 to -0.299	-0.455 log (milligram/gram) Interval -0.666 to -0.245	-0.027 log (milligram/gram) Interval -0.208 to 0.155

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin	-22.4 percent change of FMV UACR Interval -35.6 to -6.5	-39.1 percent change of FMV UACR Interval -50.0 to -25.8	-36.6 percent change of FMV UACR Interval -48.6 to -21.7	-2.6 percent change of FMV UACR Interval -18.8 to 16.8

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.

The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin	-0.210 log (milligram/gram) Interval -0.366 to -0.055	-0.614 log (milligram/gram) Interval -0.783 to -0.445	-0.516 log (milligram/gram) Interval -0.675 to -0.357	-0.112 log (milligram/gram) Interval -0.264 to 0.04

PRIMARY outcome

Timeframe: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin	-19.0 percent change of FMV UACR Interval -30.6 to -5.4	-45.9 percent change of FMV UACR Interval -54.3 to -35.9	-40.3 percent change of FMV UACR Interval -49.1 to -30.0	-10.6 percent change of FMV UACR Interval -23.2 to 4.1

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Population: Full Analysis Set (FAS): This patient set included all randomised patients who had at least one baseline measurement of UACR at Week -2, -1, or 0 and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation	40 Participants	73 Participants	66 Participants	24 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder	40 Participants	62 Participants	57 Participants	23 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)	45 Participants	67 Participants	73 Participants	31 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=124 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=107 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=106 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=127 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis	40 Participants	62 Participants	57 Participants	23 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo to BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo to BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation	19 Participants	31 Participants	30 Participants	10 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder	19 Participants	28 Participants	25 Participants	9 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)	22 Participants	31 Participants	32 Participants	14 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received placebo matching empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=56 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=50 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=66 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis	19 Participants	28 Participants	25 Participants	9 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Population: All randomised patients to of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation	21 Participants	42 Participants	36 Participants	14 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder	21 Participants	34 Participants	32 Participants	14 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward	23 Participants	36 Participants	41 Participants	17 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=51 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=56 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis	21 Participants	34 Participants	32 Participants	14 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation	68 Participants	82 Participants	81 Participants	46 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder	67 Participants	71 Participants	70 Participants	44 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=128 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=121 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=133 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)	67 Participants	87 Participants	85 Participants	53 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=124 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=107 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=106 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=127 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis	67 Participants	71 Participants	70 Participants	44 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation	33 Participants	35 Participants	39 Participants	22 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder	32 Participants	32 Participants	32 Participants	20 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=65 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=59 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=69 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)	28 Participants	41 Participants	41 Participants	25 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation	35 Participants	47 Participants	42 Participants	24 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder	35 Participants	39 Participants	38 Participants	24 Participants

SECONDARY outcome

Timeframe: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=60 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=62 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=64 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward	39 Participants	46 Participants	44 Participants	28 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=56 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=50 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=66 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis	32 Participants	32 Participants	32 Participants	20 Participants

SECONDARY outcome

Timeframe: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.

Outcome measures

Outcome measures
Measure	3 mg BI 690517 n=63 Participants This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).	10 mg BI 690517 n=51 Participants This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).	20 mg BI 690517 n=56 Participants This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).	Placebo to BI 690517 n=61 Participants This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis	35 Participants	39 Participants	38 Participants	24 Participants

Adverse Events

Run-in Period: 10 mg Empagliflozin

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Run-in Period: Placebo to Empagliflozin 10 mg

Serious events: 20 serious events

Other events: 15 other events

Deaths: 2 deaths

Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517

Serious events: 4 serious events

Other events: 11 other events

Deaths: 1 deaths

Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517

Serious events: 7 serious events

Other events: 20 other events

Deaths: 1 deaths

Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517

Serious events: 7 serious events

Other events: 13 other events

Deaths: 2 deaths

Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517

Serious events: 6 serious events

Other events: 25 other events

Deaths: 1 deaths

Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Run-in Period: 10 mg Empagliflozin n=356 participants at risk Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.	Run-in Period: Placebo to Empagliflozin 10 mg n=357 participants at risk Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.	Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 n=76 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 n=73 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 n=74 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 n=74 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 n=70 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 n=71 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 n=72 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 n=73 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
General disorders Sudden death	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Acute myocardial infarction	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.56% 2/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Cardiac failure	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.56% 2/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Cardiac failure congestive	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Coronary artery disease	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Hypertensive heart disease	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Intracardiac thrombus	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Endocrine disorders Adrenal insufficiency	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.7% 2/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.8% 2/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Gastrointestinal disorders Diarrhoea	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Abscess soft tissue	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations COVID-19	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Dengue fever	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Diverticulitis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Erysipelas	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Pneumonia	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Pyelonephritis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Sepsis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Urinary tract infection	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Injury, poisoning and procedural complications Haematuria traumatic	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Dehydration	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Hypoglycaemia	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.56% 2/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Cerebral infarction	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Dizziness	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Syncope	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Acute kidney injury	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.56% 2/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.8% 2/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Renal artery stenosis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Renal mass	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Renal and urinary disorders Subcapsular renal haematoma	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Aortic thrombosis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Coeliac artery occlusion	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Phlebitis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Angina pectoris	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Atrial flutter	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Cardiac disorders Myocardial ischaemia	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Eye disorders Cataract	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Eye disorders Glaucoma	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Gastrointestinal disorders Large intestine polyp	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Hepatobiliary disorders Cholecystitis	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Hepatobiliary disorders Hepatitis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Coronavirus pneumonia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Infections and infestations Pulmonary tuberculosis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Injury, poisoning and procedural complications Fall	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.56% 2/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Lacunar infarction	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Nervous system disorders Sciatica	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Psychiatric disorders Delirium	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Aortic stenosis	0.28% 1/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Deep vein thrombosis	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.

Other adverse events

Other adverse events
Measure	Run-in Period: 10 mg Empagliflozin n=356 participants at risk Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.	Run-in Period: Placebo to Empagliflozin 10 mg n=357 participants at risk Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.	Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 n=76 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 n=73 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 n=74 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 n=74 participants at risk This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 n=70 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 n=71 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 n=72 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.	Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 n=73 participants at risk This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period. In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Infections and infestations Upper respiratory tract infection	1.1% 4/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 5/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.3% 1/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.4% 4/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.4% 4/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.9% 2/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	4.2% 3/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.7% 2/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Investigations Cortisol decreased	0.00% 0/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.6% 2/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	4.3% 3/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.6% 4/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.8% 2/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Investigations Glomerular filtration rate decreased	1.1% 4/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.28% 1/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.3% 4/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	11.0% 8/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	9.5% 7/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.7% 2/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	9.9% 7/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	8.3% 6/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	4.1% 3/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Metabolism and nutrition disorders Hyperkalaemia	2.2% 8/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.2% 8/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	6.6% 5/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	15.1% 11/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	9.5% 7/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	6.8% 5/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	11.4% 8/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	9.9% 7/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	23.6% 17/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.5% 4/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
Vascular disorders Hypotension	0.56% 2/356 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/357 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/76 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	5.5% 4/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	2.7% 2/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/74 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	1.4% 1/70 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/71 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/72 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.	0.00% 0/73 • Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description. Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period. Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo. Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.

Additional Information

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