Trial Outcomes & Findings for A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin (NCT NCT04233801)

Last Updated: 2023-12-15

Results Overview

A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including treatment, background therapy, and visit as fixed classification effects, baseline HbA1c and baseline estimated glomerular filtration rate (eGFR) as the linear covariates, treatment by visit interaction, and baseline HbA1c by visit interaction.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

At baseline (Week 0) and at Week 24

Results posted on

2023-12-15

Participant Flow

This study was to determine the efficacy and safety of Empagliflozin added to insulin-treated type 2 diabetes patients.

4 patients did not meet eligibility criteria but randomized and treated in this trial. The rest of the subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.

Participant milestones

Participant milestones
Measure	Placebo Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Overall Study STARTED	73	73	73
Overall Study COMPLETED	73	71	69
Overall Study NOT COMPLETED	0	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Overall Study Other than listed	0	0	1
Overall Study Withdrawal by Subject	0	2	3

Baseline Characteristics

A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=73 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Total n=219 Participants Total of all reporting groups
Age, Continuous	60.1 Years STANDARD_DEVIATION 8.0 • n=5 Participants	59.9 Years STANDARD_DEVIATION 7.7 • n=7 Participants	60.7 Years STANDARD_DEVIATION 9.1 • n=5 Participants	60.2 Years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	30 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	119 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	73 Participants n=5 Participants	73 Participants n=7 Participants	73 Participants n=5 Participants	219 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Glycosylated haemoglobin A1c (HbA1c)	8.64 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.81 • n=5 Participants	8.64 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.91 • n=7 Participants	8.64 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.88 • n=5 Participants	8.64 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.87 • n=4 Participants
Time since diagnosis of diabetes	14.14 Years STANDARD_DEVIATION 7.26 • n=5 Participants	14.74 Years STANDARD_DEVIATION 7.01 • n=7 Participants	15.05 Years STANDARD_DEVIATION 7.45 • n=5 Participants	14.64 Years STANDARD_DEVIATION 7.22 • n=4 Participants
Background antidiabetic treatment Insulin + Oral antidiabetic drug (OAD)	60 Participants n=5 Participants	59 Participants n=7 Participants	59 Participants n=5 Participants	178 Participants n=4 Participants
Background antidiabetic treatment Insulin only	13 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Type of insulin Basal	32 Participants n=5 Participants	38 Participants n=7 Participants	34 Participants n=5 Participants	104 Participants n=4 Participants
Type of insulin Pre-mixed	41 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants	115 Participants n=4 Participants

PRIMARY outcome

Timeframe: At baseline (Week 0) and at Week 24

Population: Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24	-0.13 Percentage of glycosylated hemoglobin Standard Error 0.10	-1.12 Percentage of glycosylated hemoglobin Standard Error 0.10	-1.12 Percentage of glycosylated hemoglobin Standard Error 0.10

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants with glycosylated haemoglobin A1c (HbA1c) \<7.0% at Week 24 is reported.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Percentage of Participants With HbA1c<7.0% at Week 24	8.2 Percentage of participants	16.7 Percentage of participants	30.1 Percentage of participants

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 24

Change in body weight from baseline to Week 24 is reported. A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline body weight, and its interaction with visit.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change in Body Weight From Baseline to Week 24	0.01 Kilogram Standard Error 0.23	-1.99 Kilogram Standard Error 0.24	-1.31 Kilogram Standard Error 0.24

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 24

A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline SBP and its interaction with visit.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24	-1.95 Millimetre of mercury (mmHg) Standard Error 1.38	-5.56 Millimetre of mercury (mmHg) Standard Error 1.49	-2.96 Millimetre of mercury (mmHg) Standard Error 1.46

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 24

A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline DBP and its interaction with visit.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24	-1.59 Millimetre of mercury (mmHg) Standard Error 0.78	-3.37 Millimetre of mercury (mmHg) Standard Error 0.84	-0.94 Millimetre of mercury (mmHg) Standard Error 0.83

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 24

A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline FPG and its interaction with visit.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-5.56 Milligrams per deciliter (mg/dL) Standard Error 3.67	-25.61 Milligrams per deciliter (mg/dL) Standard Error 3.97	-29.69 Milligrams per deciliter (mg/dL) Standard Error 3.90

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 24

The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=72 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24	3.27 Milligrams per deciliter (mg/dL) Standard Error 7.53	-53.05 Milligrams per deciliter (mg/dL) Standard Error 8.14	-57.44 Milligrams per deciliter (mg/dL) Standard Error 7.89

SECONDARY outcome

Timeframe: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.

Population: Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.

Confirmed hypoglycemic events refer to the hypoglycaemic events with a plasma glucose value of ≤70 milligrams per deciliter (mg/dL) or where assistance was required.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=73 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Number of Participants With Confirmed Hypoglycaemic Events	8 Participants	13 Participants	7 Participants

SECONDARY outcome

Timeframe: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.

The risk of DKA had to be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty in breathing, confusion, unusual fatigue or sleepiness. In case of a suspected DKA, the investigator was to ensure that appropriate tests were performed at the earliest opportunity according to 2017 China Type 2 diabetes mellitus (T2DM) guidelines. An independent external Clinical event committee (CEC) was established to adjudicate centrally and in a blinded fashion events suspected of DKA and certain hepatic events. DKA was investigated using both broad and narrow Boehringer Ingelheim customised MedDRA query (BIcMQs).

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=73 Participants 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 Participants 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Empagliflozin 10 mg

Serious events: 10 serious events

Other events: 27 other events

Deaths: 0 deaths

Empagliflozin 25 mg

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Run-in Period

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=73 participants at risk Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 10 mg n=73 participants at risk 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Empagliflozin 25 mg n=73 participants at risk 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.	Run-in Period n=219 participants at risk Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablet orally once daily. This group includes all participants who participated the run-in period.
Infections and infestations Upper respiratory tract infection	6.8% 5/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	5.5% 4/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	5.5% 4/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	1.4% 3/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Infections and infestations Urinary tract infection	13.7% 10/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	8.2% 6/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	8.2% 6/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	4.6% 10/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Investigations Electrocardiogram T wave abnormal	6.8% 5/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	1.4% 1/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	2.7% 2/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	0.00% 0/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Investigations Protein urine present	5.5% 4/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	2.7% 2/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	4.1% 3/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	6.8% 15/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Metabolism and nutrition disorders Hyperglycaemia	9.6% 7/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	0.00% 0/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	4.1% 3/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	0.00% 0/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Metabolism and nutrition disorders Hyperlipidaemia	2.7% 2/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	5.5% 4/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	5.5% 4/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	0.46% 1/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Metabolism and nutrition disorders Hypoglycaemia	15.1% 11/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	20.5% 15/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	15.1% 11/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	4.1% 9/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Renal and urinary disorders Diabetic nephropathy	8.2% 6/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	0.00% 0/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	1.4% 1/73 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.	5.0% 11/219 • For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.

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