Trial Outcomes & Findings for Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (NCT NCT01169779)

NCT ID: NCT01169779

Last Updated: 2016-10-13

Results Overview

Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 391 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2016-10-13

Participant Flow

The study was conducted at 35 centers in 4 countries between July 21, 2010 and December 22, 2011.

A total of 655 patients were screened of which 264 (40.3%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 391 patients were randomized.

Participant milestones

Measure	Placebo 1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.	Lixisenatide 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
Overall Study STARTED	195	196
Overall Study Treated/Safety Population	194	196
Overall Study Modified Intent-to-Treat(mITT)Population	193	195
Overall Study Subgroup for Standardized Meal Test	130	121
Overall Study COMPLETED	184	179
Overall Study NOT COMPLETED	11	17

Reasons for withdrawal

Measure	Placebo 1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.	Lixisenatide 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
Overall Study Adverse Event	3	11
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	3	2
Overall Study Familial and personal reasons	3	3

Baseline Characteristics

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Baseline characteristics by cohort

Measure	Placebo n=194 Participants 1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.	Lixisenatide n=196 Participants 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.	Total n=390 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 10.5 • n=93 Participants	54.5 years STANDARD_DEVIATION 10.3 • n=4 Participants	54.8 years STANDARD_DEVIATION 10.4 • n=27 Participants
Sex: Female, Male Female	103 Participants n=93 Participants	95 Participants n=4 Participants	198 Participants n=27 Participants
Sex: Female, Male Male	91 Participants n=93 Participants	101 Participants n=4 Participants	192 Participants n=27 Participants
Race/Ethnicity, Customized Race: Asian/Oriental	194 participants n=93 Participants	196 participants n=4 Participants	390 participants n=27 Participants
Glycosylated Hemoglobin (HbA1c)	7.85 percentage of hemoglobin STANDARD_DEVIATION 0.71 • n=93 Participants	7.95 percentage of hemoglobin STANDARD_DEVIATION 0.81 • n=4 Participants	7.90 percentage of hemoglobin STANDARD_DEVIATION 0.76 • n=27 Participants
Fasting Plasma Glucose (FPG)	8.74 millimole per liter (mmol/L) STANDARD_DEVIATION 1.83 • n=93 Participants	8.84 millimole per liter (mmol/L) STANDARD_DEVIATION 2.12 • n=4 Participants	8.79 millimole per liter (mmol/L) STANDARD_DEVIATION 1.98 • n=27 Participants
2-Hour Postprandial Plasma Glucose (PPG)	17.19 mmol/L STANDARD_DEVIATION 4.06 • n=93 Participants	16.07 mmol/L STANDARD_DEVIATION 3.77 • n=4 Participants	16.65 mmol/L STANDARD_DEVIATION 3.95 • n=27 Participants
Glucose Excursion	8.14 mmol/L STANDARD_DEVIATION 3.11 • n=93 Participants	7.12 mmol/L STANDARD_DEVIATION 3.21 • n=4 Participants	7.65 mmol/L STANDARD_DEVIATION 3.20 • n=27 Participants
Body Weight	72.74 kilogram (kg) STANDARD_DEVIATION 13.64 • n=93 Participants	73.18 kilogram (kg) STANDARD_DEVIATION 13.93 • n=4 Participants	72.96 kilogram (kg) STANDARD_DEVIATION 13.77 • n=27 Participants
Duration of Diabetes	6.84 years STANDARD_DEVIATION 4.80 • n=93 Participants	6.45 years STANDARD_DEVIATION 4.64 • n=4 Participants	6.64 years STANDARD_DEVIATION 4.72 • n=27 Participants
Body Mass Index (BMI)	27.08 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.75 • n=93 Participants	26.75 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.86 • n=4 Participants	26.91 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.80 • n=27 Participants
Metformin Daily Dose	1363.4 milligram (mg) per day STANDARD_DEVIATION 221.9 • n=93 Participants	1369.9 milligram (mg) per day STANDARD_DEVIATION 219.9 • n=4 Participants	1366.7 milligram (mg) per day STANDARD_DEVIATION 220.7 • n=27 Participants
Number of Patients With Sulfonylurea use at Baseline Yes	92 participants n=93 Participants	82 participants n=4 Participants	174 participants n=27 Participants
Number of Patients With Sulfonylurea use at Baseline No	102 participants n=93 Participants	114 participants n=4 Participants	216 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.

Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=188 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=185 Participants 1-step initiation regimen of lixisenatide.
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	-0.47 percentage of hemoglobin Standard Error 0.104	-0.83 percentage of hemoglobin Standard Error 0.102

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.

Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=191 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=190 Participants 1-step initiation regimen of lixisenatide.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-0.21 mmol/L Standard Error 0.200	-0.69 mmol/L Standard Error 0.197

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.

Outcome measures

Measure	Placebo n=116 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=107 Participants 1-step initiation regimen of lixisenatide.
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24	-1.33 mmol/L Standard Error 0.376	-5.61 mmol/L Standard Error 0.393

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.

Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=191 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=188 Participants 1-step initiation regimen of lixisenatide.
Change From Baseline in Body Weight at Week 24	-1.24 kilogram Standard Error 0.273	-1.50 kilogram Standard Error 0.267

SECONDARY outcome

Timeframe: Week 24

Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=188 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=185 Participants 1-step initiation regimen of lixisenatide.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24	38.8 percentage of participants	53.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=188 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=185 Participants 1-step initiation regimen of lixisenatide.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24	18.1 percentage of participants	32.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with Baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.

Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.

Outcome measures

Measure	Placebo n=116 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=106 Participants 1-step initiation regimen of lixisenatide.
Change From Baseline in Glucose Excursion at Week 24	-0.79 mmol/L Standard Error 0.340	-4.78 mmol/L Standard Error 0.356

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT population.

Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=193 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=195 Participants 1-step initiation regimen of lixisenatide.
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period	6.7 percentage of participants	3.6 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 24

Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.

The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.

Outcome measures

Measure	Placebo n=191 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=188 Participants 1-step initiation regimen of lixisenatide.
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24	14.7 percentage of participants	19.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: First dose of study drug up to 3 days after the last dose administration

Population: Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.

Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.

Outcome measures

Measure	Placebo n=194 Participants 1-step initiation regimen of volume matching placebo.	Lixisenatide n=196 Participants 1-step initiation regimen of lixisenatide.
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia Severe symptomatic hypoglycemia	0 participants	0 participants
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia Symptomatic hypoglycemia	5 participants	11 participants

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Lixisenatide

Serious events: 3 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=194 participants at risk 1-step initiation regimen of volume matching placebo.	Lixisenatide n=196 participants at risk 1-step initiation regimen of lixisenatide.
Immune system disorders Anaphylactic shock	0.00% 0/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.51% 1/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Nervous system disorders Cerebral infarction	0.00% 0/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.51% 1/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Cardiac disorders Acute myocardial infarction	0.00% 0/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.51% 1/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Vascular disorders Hypertension	0.52% 1/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.00% 0/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Gastrointestinal disorders Abdominal pain	0.00% 0/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.51% 1/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Hepatobiliary disorders Hepatic function abnormal	0.52% 1/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.00% 0/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.52% 1/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.00% 0/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Reproductive system and breast disorders Prostatitis	0.52% 1/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	0.00% 0/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.

Other adverse events

Measure	Placebo n=194 participants at risk 1-step initiation regimen of volume matching placebo.	Lixisenatide n=196 participants at risk 1-step initiation regimen of lixisenatide.
Infections and infestations Upper respiratory tract infection	4.1% 8/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	6.1% 12/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Metabolism and nutrition disorders Hyperuricaemia	5.2% 10/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	3.6% 7/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Metabolism and nutrition disorders Hypoglycaemia	4.6% 9/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	9.2% 18/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Nervous system disorders Dizziness	4.1% 8/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	8.7% 17/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Gastrointestinal disorders Nausea	2.6% 5/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	16.3% 32/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Gastrointestinal disorders Vomiting	1.0% 2/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	7.7% 15/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Renal and urinary disorders Diabetic nephropathy	6.7% 13/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	6.6% 13/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Investigations Blood glucose decreased	2.6% 5/194 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.	5.1% 10/196 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days for both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact-us@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER