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24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (GetGoal-Duo1)

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ClinicalTrials.gov Identifier: NCT00975286
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Insulin glargine
Device: Pen auto-injector
Drug: Metformin
Drug: Thiazolidinedione (TZD)
Enrollment 446
Recruitment Details The study was conducted at 140 centers in 25 countries between October 13, 2009 and August 01, 2011.
Pre-assignment Details 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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 223 [1] 223
Safety Population 223 [2] 223
Modified Intent-to-Treat(mITT)Population 223 [3] 223
Completed 211 194
Not Completed 12 29
Reason Not Completed
Adverse Event             9             19
Protocol Violation             1             2
Withdrawal by Subject             0             2
Familial and Personal Reasons             2             2
Poor Compliance to Protocol             0             2
Sponsor Decision             0             2
[1]
Randomized.
[2]
All patients who were exposed to at least 1 dose, regardless of amount of treatment administered.
[3]
All patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment.
Arm/Group Title Placebo Lixisenatide Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 223 223 446
Hide Baseline Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 223 participants 446 participants
56.1  (10.2) 56.4  (9.7) 56.2  (9.9)
[1]
Measure Description: Age at screening is reported.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 223 participants 446 participants
Female
110
  49.3%
114
  51.1%
224
  50.2%
Male
113
  50.7%
109
  48.9%
222
  49.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 223 participants 223 participants 446 participants
Race: Caucasian/White 167 165 332
Race: Black 11 9 20
Race: Asian/Oriental 43 44 87
Race: Other 2 5 7
Ethnicity: Hispanic 49 52 101
Ethnicity: Non Hispanic 174 171 345
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 223 participants 223 participants 446 participants
7.60  (0.54) 7.56  (0.55) 7.58  (0.54)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 223 participants 223 participants 446 participants
6.70  (1.97) 6.55  (1.72) 6.62  (1.85)
2-Hour Postprandial Plasma Glucose (PPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 223 participants 223 participants 446 participants
12.79  (3.69) 12.90  (3.94) 12.85  (3.81)
[1]
Measure Description: The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients evaluable for this Baseline characteristic were 221 and 219 for Placebo and Lixisenatide arm, respectively.
Glucose Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 223 participants 223 participants 446 participants
6.33  (3.54) 6.24  (4.35) 6.29  (3.96)
[1]
Measure Description: Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients evaluable for this Baseline characteristic were 221 and 219 for Placebo and Lixisenatide arm, respectively.
Average 7-Point Self Monitored Plasma Glucose (SMPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 223 participants 223 participants 446 participants
8.26  (1.52) 8.20  (1.47) 8.23  (1.49)
[1]
Measure Description: Patients recorded a 7-point plasma glucose profile 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. Number of patients evaluable for this Baseline characteristic were 221 and 221 for Placebo and Lixisenatide arm, respectively.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 223 participants 223 participants 446 participants
86.75  (20.41) 87.31  (21.76) 87.03  (21.07)
Average Insulin Glargine Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per day
Number Analyzed 223 participants 223 participants 446 participants
44.24  (19.86) 43.44  (18.84) 43.84  (19.34)
[1]
Measure Description: Insulin glargine average daily dose at Baseline is the average daily dose for the week prior to Visit 12 (Week -1).
Treatment Satisfaction Score (Diabetes Treatment Satisfaction Questionnaire [DTSQ])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 223 participants 223 participants 446 participants
31.5  (5.1) 31.7  (4.5) 31.6  (4.8)
[1]
Measure Description: 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 (worst case) to 6 (best case) except Q2 and 3 where 0 (best case) to 6 (worst case). Six items (Q1 and 4-8) 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 score represented good perceived blood glucose control.
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 223 participants 446 participants
8.72  (5.82) 9.62  (6.03) 9.17  (5.94)
[1]
Measure Description: Duration of diabetes at screening is reported.
Metformin Daily Dose  
Mean (Standard Deviation)
Unit of measure:  Milligram (mg) per day
Number Analyzed 223 participants 223 participants 446 participants
2058.1  (430.6) 2039.2  (405.3) 2048.7  (417.8)
Number of Patients With Thiazolidinedione (TZD) use at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 223 participants 223 participants 446 participants
Yes 27 27 54
No 196 196 392
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 223 participants 223 participants 446 participants
31.65  (6.01) 31.99  (6.63) 31.82  (6.32)
[1]
Measure Description: BMI was calculated by dividing body weight by the height squared.
Number of Patients With Categorical BMI  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 223 participants 223 participants 446 participants
Less than 30 103 103 206
Greater than or equal to 30 120 120 240
1.Primary Outcome
Title Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 221 215
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.40  (0.092) -0.71  (0.091)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lixisenatide
Comments To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (<8.0,>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter [Least squares (LS) mean difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.463 to -0.171
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.074
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 204 194
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.08  (0.481) -3.09  (0.482)
3.Secondary Outcome
Title Change From Baseline in Glucose Excursion at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 204 194
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.33  (0.461) -3.42  (0.462)
4.Secondary Outcome
Title Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 214 210
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.08  (0.179) -0.47  (0.178)
5.Secondary Outcome
Title Change From Baseline in Body Weight at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 220 217
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
1.16  (0.330) 0.28  (0.331)
6.Secondary Outcome
Title Change From Baseline in Average Insulin Glargine Daily Dose at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 223 222
Least Squares Mean (Standard Error)
Unit of Measure: units per day
5.34  (1.256) 3.10  (1.260)
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 220 214
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.46  (0.214) 0.34  (0.213)
8.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 221 215
Measure Type: Number
Unit of Measure: percentage of participants
38.5 56.3
9.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 221 215
Measure Type: Number
Unit of Measure: percentage of participants
16.3 32.1
10.Secondary Outcome
Title Percentage of Patients Requiring Rescue Therapy During the Double-blind Period
Hide Description 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.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: percentage of participants
0.4 0.4
11.Secondary Outcome
Title Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 209 201
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.65  (0.545) 0.88  (0.543)
12.Other Pre-specified Outcome
Title Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 220 217
Measure Type: Number
Unit of Measure: percentage of participants
3.2 5.1
13.Other Pre-specified Outcome
Title Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
Hide Description 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.
Time Frame First dose of study drug up to 3 days after the last dose administration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 223 223
Measure Type: Number
Unit of Measure: participants
Symptomatic hypoglycemia 30 50
Severe symptomatic hypoglycemia 0 1
Time Frame First dose of study drug up to 3 days after the last dose administration
Adverse Event Reporting Description 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.
 
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description 2-step initiation regimen of volume matching placebo. 2-step initiation regimen of lixisenatide.
All-Cause Mortality
Placebo Lixisenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lixisenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   10/223 (4.48%)   17/223 (7.62%) 
Cardiac disorders     
Acute myocardial infarction * 1  1/223 (0.45%)  0/223 (0.00%) 
Angina pectoris * 1  0/223 (0.00%)  1/223 (0.45%) 
Angina unstable * 1  2/223 (0.90%)  2/223 (0.90%) 
Cardiac failure congestive * 1  0/223 (0.00%)  1/223 (0.45%) 
Myocardial infarction * 1  1/223 (0.45%)  0/223 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia * 1  0/223 (0.00%)  1/223 (0.45%) 
Colitis ischaemic * 1  1/223 (0.45%)  0/223 (0.00%) 
Haemorrhoids * 1  0/223 (0.00%)  1/223 (0.45%) 
Upper gastrointestinal haemorrhage * 1  1/223 (0.45%)  0/223 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/223 (0.45%)  0/223 (0.00%) 
Infections and infestations     
Gastroenteritis * 1  0/223 (0.00%)  1/223 (0.45%) 
Pneumonia * 1  1/223 (0.45%)  1/223 (0.45%) 
Urosepsis * 1  0/223 (0.00%)  1/223 (0.45%) 
Injury, poisoning and procedural complications     
Head injury * 1  0/223 (0.00%)  1/223 (0.45%) 
Subdural haematoma * 1  0/223 (0.00%)  1/223 (0.45%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/223 (0.00%)  1/223 (0.45%) 
Hypoglycaemic unconsciousness * 1  0/223 (0.00%)  1/223 (0.45%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/223 (0.45%)  0/223 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer * 1  0/223 (0.00%)  1/223 (0.45%) 
Multiple myeloma * 1  1/223 (0.45%)  0/223 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  0/223 (0.00%)  1/223 (0.45%) 
Transient ischaemic attack * 1  0/223 (0.00%)  1/223 (0.45%) 
Psychiatric disorders     
Schizophrenia, paranoid type * 1  0/223 (0.00%)  1/223 (0.45%) 
Suicide attempt * 1  1/223 (0.45%)  0/223 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/223 (0.00%)  1/223 (0.45%) 
Pulmonary oedema * 1  1/223 (0.45%)  0/223 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/223 (0.45%)  0/223 (0.00%) 
Surgical and medical procedures     
Coronary angioplasty * 1  0/223 (0.00%)  1/223 (0.45%) 
Coronary arterial stent insertion * 1  0/223 (0.00%)  1/223 (0.45%) 
Vascular disorders     
Deep vein thrombosis * 1  1/223 (0.45%)  0/223 (0.00%) 
Hypertension * 1  0/223 (0.00%)  1/223 (0.45%) 
Hypovolaemic shock * 1  0/223 (0.00%)  1/223 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lixisenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   81/223 (36.32%)   127/223 (56.95%) 
Gastrointestinal disorders     
Diarrhoea * 1  7/223 (3.14%)  15/223 (6.73%) 
Nausea * 1  11/223 (4.93%)  61/223 (27.35%) 
Vomiting * 1  3/223 (1.35%)  21/223 (9.42%) 
Infections and infestations     
Influenza * 1  14/223 (6.28%)  11/223 (4.93%) 
Nasopharyngitis * 1  12/223 (5.38%)  11/223 (4.93%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1 [1]  43/223 (19.28%)  61/223 (27.35%) 
Nervous system disorders     
Dizziness * 1  6/223 (2.69%)  12/223 (5.38%) 
Headache * 1  8/223 (3.59%)  22/223 (9.87%) 
Tremor * 1  4/223 (1.79%)  13/223 (5.83%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Hypoglycaemia adverse event is based on investigator reported hypoglycaemia.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00975286     History of Changes
Other Study ID Numbers: EFC10781
EudraCT : 2008-007335-40
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016