Trial Outcomes & Findings for Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2) (NCT NCT02414958)

Last Updated: 2019-01-03

Results Overview

Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

730 participants

Primary outcome timeframe

Baseline to week 26

Results posted on

2019-01-03

Participant Flow

Randomised, double-blind, placebo-controlled, parallel group, 52-week trial comparing 2 oral once daily doses (10 mg and 25 mg) of empagliflozin with placebo in patients with type 1 diabetes mellitus (T1DM), each as adjunctive to optimised insulin therapy.

6-week T1DM therapy (insulin) optimisation period followed by a 2-week placebo run-in period before randomisation. Patients who successfully completed both of the periods were randomised into the 52-week double-blind treatment period. All treatments were administered in addition to optimised insulin therapy.

Participant milestones

Participant milestones
Measure	Placebo Matching Empagliflozin Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Overall Study STARTED	243	243	244
Overall Study COMPLETED	211	223	230
Overall Study NOT COMPLETED	32	20	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching Empagliflozin Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Overall Study Adverse Event	6	6	3
Overall Study Protocol Violation	10	3	1
Overall Study Lost to Follow-up	7	4	0
Overall Study Withdrawal by Subject	5	3	5
Overall Study Other than specified	4	4	5

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Total n=730 Participants Total of all reporting groups
Age, Continuous	44.2 Years STANDARD_DEVIATION 13.6 • n=5 Participants • RS	45.7 Years STANDARD_DEVIATION 12.5 • n=7 Participants • RS	45.3 Years STANDARD_DEVIATION 14.0 • n=5 Participants • RS	45.0 Years STANDARD_DEVIATION 13.4 • n=4 Participants • RS
Sex: Female, Male Female	133 Participants n=5 Participants • RS	125 Participants n=7 Participants • RS	131 Participants n=5 Participants • RS	389 Participants n=4 Participants • RS
Sex: Female, Male Male	110 Participants n=5 Participants • RS	118 Participants n=7 Participants • RS	113 Participants n=5 Participants • RS	341 Participants n=4 Participants • RS
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants • RS	4 Participants n=7 Participants • RS	6 Participants n=5 Participants • RS	17 Participants n=4 Participants • RS
Ethnicity (NIH/OMB) Not Hispanic or Latino	236 Participants n=5 Participants • RS	239 Participants n=7 Participants • RS	238 Participants n=5 Participants • RS	713 Participants n=4 Participants • RS
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • RS	0 Participants n=7 Participants • RS	0 Participants n=5 Participants • RS	0 Participants n=4 Participants • RS
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • RS	0 Participants n=7 Participants • RS	0 Participants n=5 Participants • RS	0 Participants n=4 Participants • RS
Race (NIH/OMB) Asian	7 Participants n=5 Participants • RS	6 Participants n=7 Participants • RS	10 Participants n=5 Participants • RS	23 Participants n=4 Participants • RS
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • RS	1 Participants n=7 Participants • RS	0 Participants n=5 Participants • RS	1 Participants n=4 Participants • RS
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants • RS	6 Participants n=7 Participants • RS	4 Participants n=5 Participants • RS	17 Participants n=4 Participants • RS
Race (NIH/OMB) White	227 Participants n=5 Participants • RS	230 Participants n=7 Participants • RS	230 Participants n=5 Participants • RS	687 Participants n=4 Participants • RS
Race (NIH/OMB) More than one race	2 Participants n=5 Participants • RS	0 Participants n=7 Participants • RS	0 Participants n=5 Participants • RS	2 Participants n=4 Participants • RS
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • RS	0 Participants n=7 Participants • RS	0 Participants n=5 Participants • RS	0 Participants n=4 Participants • RS

PRIMARY outcome

Timeframe: Baseline to week 26

Population: Full analysis set (FAS) (observed cases \[OC\]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement; the FAS was the basis for the primary efficacy analysis

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26	0.09 Percentage (%) Standard Error 0.04	-0.44 Percentage (%) Standard Error 0.04	-0.44 Percentage (%) Standard Error 0.04

PRIMARY outcome

Timeframe: Baseline to week 26

Population: Modified intention-to-treat set (mITT) (observed case - all data \[OC-AD\]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement.

Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \[OC-AD\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )	0.09 Percentage (%) Standard Error 0.04	-0.43 Percentage (%) Standard Error 0.04	-0.42 Percentage (%) Standard Error 0.04

SECONDARY outcome

Timeframe: Week 5 to Week 26, Week 1 to Week 26

Population: FAS (OC)

This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG) Week 5 to 26	8.92 Event per patient year Interval 7.15 to 11.14	6.64 Event per patient year Interval 5.32 to 8.28	6.48 Event per patient year Interval 5.18 to 8.12
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG) Week 1 to 26	9.13 Event per patient year Interval 7.36 to 11.34	7.07 Event per patient year Interval 5.7 to 8.76	7.15 Event per patient year Interval 5.75 to 8.88

SECONDARY outcome

Timeframe: Baseline to week 26

Population: FAS (OC)

Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Body Weight at Week 26	-0.10 Kilogram (kg) Standard Error 0.21	-2.79 Kilogram (kg) Standard Error 0.20	-3.37 Kilogram (kg) Standard Error 0.20

SECONDARY outcome

Timeframe: Week 23 to 26

Population: FAS observed cases excluding data after use of paracetamol (OC-P)

Change from baseline in the percentage of time spent in target glucose range of \>70 to ≤180 mg/dL (\>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26	-1.13 Percentage of time Standard Error 0.72	10.73 Percentage of time Standard Error 0.71	11.74 Percentage of time Standard Error 0.70

SECONDARY outcome

Timeframe: Week 23 to 26

Population: FAS observed cases excluding data after use of paracetamol (OC-P)

Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26	1.62 milligrams (mg)/ deciliter (dL) Standard Error 1.21	-15.30 milligrams (mg)/ deciliter (dL) Standard Error 1.18	-17.41 milligrams (mg)/ deciliter (dL) Standard Error 1.16

SECONDARY outcome

Timeframe: Baseline to week 26

Population: FAS (OC)

Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26	-0.010 Unit/kilogram (U/kg) Standard Error 0.007	-0.102 Unit/kilogram (U/kg) Standard Error 0.007	-0.100 Unit/kilogram (U/kg) Standard Error 0.007

SECONDARY outcome

Timeframe: Baseline to week 26

Population: FAS observed cases excluding data after change in use of anti-hypertensives (OC-H)

Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.

Outcome measures

Outcome measures
Measure	Placebo Matching Empagliflozin n=243 Participants Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks	Empagliflozin 10 mg n=243 Participants Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 Participants Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 DBP	-0.3 Millimeters of mercury (mmHg) Standard Error 0.5	-1.6 Millimeters of mercury (mmHg) Standard Error 0.5	-2.6 Millimeters of mercury (mmHg) Standard Error 0.5
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 SBP	-0.8 Millimeters of mercury (mmHg) Standard Error 0.7	-2.9 Millimeters of mercury (mmHg) Standard Error 0.7	-4.5 Millimeters of mercury (mmHg) Standard Error 0.7

Adverse Events

Placebo Matching Empagliflozin

Serious events: 28 serious events

Other events: 197 other events

Deaths: 0 deaths

Empagliflozin 10 mg

Serious events: 43 serious events

Other events: 197 other events

Deaths: 0 deaths

Empagliflozin 25 mg

Serious events: 26 serious events

Other events: 195 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo Matching Empagliflozin n=243 participants at risk Patients administered placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 10 mg n=243 participants at risk Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.	Empagliflozin 25 mg n=244 participants at risk Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks.
Gastrointestinal disorders Diarrhoea	3.7% 9/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	5.3% 13/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	3.3% 8/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Gastrointestinal disorders Nausea	5.8% 14/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	4.9% 12/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	5.7% 14/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Gastrointestinal disorders Vomiting	4.9% 12/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	7.8% 19/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	4.9% 12/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Influenza	4.5% 11/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	8.2% 20/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	4.9% 12/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Nasopharyngitis	16.9% 41/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	21.4% 52/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	17.6% 43/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Sinusitis	5.3% 13/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	5.8% 14/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	3.7% 9/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Upper respiratory tract infection	10.3% 25/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	6.2% 15/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	11.1% 27/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Urinary tract infection	11.9% 29/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	15.2% 37/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	8.2% 20/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Infections and infestations Vulvovaginal mycotic infection	0.82% 2/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	3.7% 9/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	5.7% 14/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Investigations Blood ketone body increased	4.1% 10/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	7.4% 18/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	8.2% 20/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
Metabolism and nutrition disorders Hypoglycaemia	62.6% 152/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	63.4% 154/243 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.	60.2% 147/244 • From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.

Additional Information

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Email: [email protected]

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