Trial Outcomes & Findings for 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (NCT NCT00975286)

Last Updated: 2016-10-11

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 14 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 assessment for at least 1 efficacy variable, were required.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

446 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2016-10-11

Participant Flow

The study was conducted at 140 centers in 25 countries between October 13, 2009 and August 01, 2011.

A total of 1470 patients were screened of which 1024 were screen or run-in 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 9%). A total of 446 patients were randomized.

Participant milestones

Participant milestones
Measure	Placebo 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.	Lixisenatide 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Overall Study STARTED	223	223
Overall Study Safety Population	223	223
Overall Study Modified Intent-to-Treat(mITT)Population	223	223
Overall Study COMPLETED	211	194
Overall Study NOT COMPLETED	12	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.	Lixisenatide 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Overall Study Adverse Event	9	19
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	0	2
Overall Study Familial and Personal Reasons	2	2
Overall Study Poor Compliance to Protocol	0	2
Overall Study Sponsor Decision	0	2

Baseline Characteristics

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=223 Participants 2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.	Lixisenatide n=223 Participants 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.	Total n=446 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	56.4 years STANDARD_DEVIATION 9.7 • n=7 Participants	56.2 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	114 Participants n=7 Participants	224 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	109 Participants n=7 Participants	222 Participants n=5 Participants
Race/Ethnicity, Customized Race: Caucasian/White	167 participants n=5 Participants	165 participants n=7 Participants	332 participants n=5 Participants
Race/Ethnicity, Customized Race: Black	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Race: Asian/Oriental	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Race/Ethnicity, Customized Race: Other	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic	49 participants n=5 Participants	52 participants n=7 Participants	101 participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Non Hispanic	174 participants n=5 Participants	171 participants n=7 Participants	345 participants n=5 Participants
Glycosylated Hemoglobin (HbA1c)	7.60 percentage of hemoglobin STANDARD_DEVIATION 0.54 • n=5 Participants	7.56 percentage of hemoglobin STANDARD_DEVIATION 0.55 • n=7 Participants	7.58 percentage of hemoglobin STANDARD_DEVIATION 0.54 • n=5 Participants
Fasting Plasma Glucose (FPG)	6.70 millimole per liter (mmol/L) STANDARD_DEVIATION 1.97 • n=5 Participants	6.55 millimole per liter (mmol/L) STANDARD_DEVIATION 1.72 • n=7 Participants	6.62 millimole per liter (mmol/L) STANDARD_DEVIATION 1.85 • n=5 Participants
2-Hour Postprandial Plasma Glucose (PPG)	12.79 mmol/L STANDARD_DEVIATION 3.69 • n=5 Participants	12.90 mmol/L STANDARD_DEVIATION 3.94 • n=7 Participants	12.85 mmol/L STANDARD_DEVIATION 3.81 • n=5 Participants
Glucose Excursion	6.33 mmol/L STANDARD_DEVIATION 3.54 • n=5 Participants	6.24 mmol/L STANDARD_DEVIATION 4.35 • n=7 Participants	6.29 mmol/L STANDARD_DEVIATION 3.96 • n=5 Participants
Average 7-Point Self Monitored Plasma Glucose (SMPG)	8.26 mmol/L STANDARD_DEVIATION 1.52 • n=5 Participants	8.20 mmol/L STANDARD_DEVIATION 1.47 • n=7 Participants	8.23 mmol/L STANDARD_DEVIATION 1.49 • n=5 Participants
Body Weight	86.75 kilogram (kg) STANDARD_DEVIATION 20.41 • n=5 Participants	87.31 kilogram (kg) STANDARD_DEVIATION 21.76 • n=7 Participants	87.03 kilogram (kg) STANDARD_DEVIATION 21.07 • n=5 Participants
Average Insulin Glargine Daily Dose	44.24 units per day STANDARD_DEVIATION 19.86 • n=5 Participants	43.44 units per day STANDARD_DEVIATION 18.84 • n=7 Participants	43.84 units per day STANDARD_DEVIATION 19.34 • n=5 Participants
Treatment Satisfaction Score (Diabetes Treatment Satisfaction Questionnaire [DTSQ])	31.5 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants	31.7 units on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	31.6 units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants
Duration of Diabetes	8.72 years STANDARD_DEVIATION 5.82 • n=5 Participants	9.62 years STANDARD_DEVIATION 6.03 • n=7 Participants	9.17 years STANDARD_DEVIATION 5.94 • n=5 Participants
Metformin Daily Dose	2058.1 milligram (mg) per day STANDARD_DEVIATION 430.6 • n=5 Participants	2039.2 milligram (mg) per day STANDARD_DEVIATION 405.3 • n=7 Participants	2048.7 milligram (mg) per day STANDARD_DEVIATION 417.8 • n=5 Participants
Number of Patients With Thiazolidinedione (TZD) use at Baseline Yes	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants
Number of Patients With Thiazolidinedione (TZD) use at Baseline No	196 participants n=5 Participants	196 participants n=7 Participants	392 participants n=5 Participants
Body Mass Index (BMI)	31.65 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.01 • n=5 Participants	31.99 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.63 • n=7 Participants	31.82 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.32 • n=5 Participants
Number of Patients With Categorical BMI Less than 30	103 participants n=5 Participants	103 participants n=7 Participants	206 participants n=5 Participants
Number of Patients With Categorical BMI Greater than or equal to 30	120 participants n=5 Participants	120 participants n=7 Participants	240 participants n=5 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. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.

Outcome measures

Outcome measures
Measure	Placebo n=221 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=215 Participants 2-step initiation regimen of lixisenatide.
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	-0.40 percentage of hemoglobin Standard Error 0.092	-0.71 percentage of hemoglobin Standard Error 0.091

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).

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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=194 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24	0.08 mmol/L Standard Error 0.481	-3.09 mmol/L Standard Error 0.482

SECONDARY outcome

Timeframe: Baseline, Week 24

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

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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=194 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Glucose Excursion at Week 24	-0.33 mmol/L Standard Error 0.461	-3.42 mmol/L Standard Error 0.462

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.

Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. 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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=214 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=210 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24	-0.08 mmol/L Standard Error 0.179	-0.47 mmol/L Standard Error 0.178

SECONDARY 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. Missing data was imputed using LOCF.

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 assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=220 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=217 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Body Weight at Week 24	1.16 kilogram Standard Error 0.330	0.28 kilogram Standard Error 0.331

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Change was calculated by subtracting the 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. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=223 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=222 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Average Insulin Glargine Daily Dose at Week 24	5.34 units per day Standard Error 1.256	3.10 units per day Standard Error 1.260

SECONDARY outcome

Timeframe: Baseline, Week 24

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

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 assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=220 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=214 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	0.46 mmol/L Standard Error 0.214	0.34 mmol/L Standard Error 0.213

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 14 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 assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=221 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=215 Participants 2-step initiation regimen of lixisenatide.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24	38.5 percentage of participants	56.3 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.

Outcome measures

Outcome measures
Measure	Placebo n=221 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=215 Participants 2-step initiation regimen of lixisenatide.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24	16.3 percentage of participants	32.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: mITT population.

Routine fasting SMPG, central laboratory FPG and HbA1c 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 were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c \>9%, from Week 8 to Week 24: fasting SMPG/FPG \>180 mg/dL (10.0 mmol/L) or HbA1c \>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=223 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=223 Participants 2-step initiation regimen of lixisenatide.
Percentage of Patients Requiring Rescue Therapy During the Double-blind Period	0.4 percentage of participants	0.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

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

Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. 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 assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=209 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=201 Participants 2-step initiation regimen of lixisenatide.
Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24	0.65 units on a scale Standard Error 0.545	0.88 units on a scale Standard Error 0.543

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 assessment for at least 1 efficacy variable, were required.

Outcome measures

Outcome measures
Measure	Placebo n=220 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=217 Participants 2-step initiation regimen of lixisenatide.
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24	3.2 percentage of participants	5.1 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

Outcome measures
Measure	Placebo n=223 Participants 2-step initiation regimen of volume matching placebo.	Lixisenatide n=223 Participants 2-step initiation regimen of lixisenatide.
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia Symptomatic hypoglycemia	30 participants	50 participants
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia Severe symptomatic hypoglycemia	0 participants	1 participants

Adverse Events

Placebo

Serious events: 10 serious events

Other events: 81 other events

Deaths: 0 deaths

Lixisenatide

Serious events: 17 serious events

Other events: 127 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=223 participants at risk 2-step initiation regimen of volume matching placebo.	Lixisenatide n=223 participants at risk 2-step initiation regimen of lixisenatide.
Infections and infestations Influenza	6.3% 14/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	4.9% 11/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.
Infections and infestations Nasopharyngitis	5.4% 12/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	4.9% 11/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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	19.3% 43/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	27.4% 61/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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	2.7% 6/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	5.4% 12/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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 Headache	3.6% 8/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	9.9% 22/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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 Tremor	1.8% 4/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	5.8% 13/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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 Diarrhoea	3.1% 7/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	6.7% 15/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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	4.9% 11/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	27.4% 61/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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	1.3% 3/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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.	9.4% 21/223 • First dose of study drug up to 3 days after the last dose administration Median exposure to study treatment was 169 days in 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: [email protected]

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