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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA) (GETGOAL-L-ASIA)

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ClinicalTrials.gov Identifier: NCT00866658
Recruitment Status : Completed
First Posted : March 20, 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 Diabetes Mellitus, Type 2
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Sulfonylurea
Drug: Basal Insulin
Enrollment 311
Recruitment Details The study was conducted at 57 centers in 4 countries between March 10, 2009 and June 23, 2010.
Pre-assignment Details A total of 437 patients were screened of which 126 (28.8%) 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 311 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 157 [1] 154
Safety Population 157 [2] 154
Modified Intent-to-Treat(mITT)Population 157 [3] 154
Completed 144 133
Not Completed 13 21
Reason Not Completed
Adverse Event             5             14
Lack of Efficacy             2             1
Withdrawal by Subject             1             0
Protocol Violation             1             1
Familial and Personal Reasons             4             5
[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 157 154 311
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 154 participants 311 participants
58.0  (10.1) 58.7  (10.2) 58.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Female
77
  49.0%
85
  55.2%
162
  52.1%
Male
80
  51.0%
69
  44.8%
149
  47.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Race: Asian/Oriental 157 154 311
Ethnicity: Non Hispanic 157 154 311
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 157 participants 154 participants 311 participants
8.52  (0.78) 8.54  (0.73) 8.53  (0.76)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 157 participants 154 participants 311 participants
65.60  (12.47) 65.93  (13.00) 65.77  (12.72)
2-Hour Postprandial Plasma Glucose (PPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 157 participants 154 participants 311 participants
17.75  (3.94) 17.81  (3.36) 17.78  (3.66)
[1]
Measure Description: The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 156 and 152 for Placebo and Lixisenatide treatment arms, respectively.
Number of Patients With Screening HbA1c Less Than 8%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
36 35 71
Number of Patients With Screening HbA1c Greater Than or Equal to 8%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
121 119 240
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 157 participants 154 participants 311 participants
7.75  (2.25) 7.67  (2.32) 7.71  (2.28)
Average 7-point Self-Monitored Plasma Glucose (SMPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 157 participants 154 participants 311 participants
11.42  (2.46) 11.58  (2.51) 11.51  (2.48)
[1]
Measure Description: Here, number of patients analyzed = 139 and 147 for Placebo and Lixisenatide treatment arms, respectively.
Glucose Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 157 participants 154 participants 311 participants
9.70  (4.19) 9.72  (3.27) 9.71  (3.75)
[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 analyzed = 156 and 152 for Placebo and Lixisenatide treatment arms, respectively.
Basal Insulin Treatment Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 154 participants 311 participants
3.01  (4.27) 2.94  (3.67) 2.97  (3.97)
[1]
Measure Description: Basal insulin treatment duration is reported at screening. Number of patients analyzed = 155 and 154 for Placebo and Lixisenatide treatment arms, respectively.
Total Insulin Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per day
Number Analyzed 157 participants 154 participants 311 participants
24.11  (14.18) 24.85  (13.96) 24.48  (14.05)
[1]
Measure Description: Total insulin dose is reported at screening.
Number of Patients With Insulin Therapy at Screening   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Glargine 92 95 187
Detemir 42 41 83
Neutral Protamine Hagedorn (NPH) 21 18 39
Premix (Mixed Insulin) 2 0 2
[1]
Measure Description: NPH included isophane insulin and insulin human injection, isophane. Premix insulin included Novomix.
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 154 participants 311 participants
14.13  (7.72) 13.71  (7.73) 13.92  (7.71)
[1]
Measure Description: Duration of diabetes is reported at screening.
Sulfonylurea Treatment Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 154 participants 311 participants
6.80  (5.24) 5.33  (4.83) 6.07  (5.08)
[1]
Measure Description: Sulfonylurea treatment duration is reported at screening. Number of patients analyzed = 101 and 100 for Placebo and Lixisenatide treatment arms, respectively.
Number of Patients With Sulfonylurea Use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 154 participants 311 participants
Yes 111 108 219
No 46 46 92
[1]
Measure Description: Number of patients with sulfonylurea urea is reported at screening.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 157 participants 154 participants 311 participants
25.15  (3.94) 25.36  (3.69) 25.26  (3.82)
[1]
Measure Description: Body mass index was calculated by dividing body weight (kilogram) by the height (meters) squared.
1.Primary Outcome
Title Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) 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: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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 154 146
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
0.11  (0.131) -0.77  (0.137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lixisenatide
Comments To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t 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 co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (<8.0, >=8.0%),sulfonylurea 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 -0.88
Confidence Interval (2-Sided) 95%
-1.116 to -0.650
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.118
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. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 142 131
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.14  (0.563) -7.96  (0.598)
3.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. 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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 150
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
0.06  (0.271) -0.38  (0.284)
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. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 138 142
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.56  (0.271) -1.91  (0.272)
5.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. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 148
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.25  (0.302) -0.42  (0.314)
6.Secondary Outcome
Title Change From Screening in Total Insulin Dose at Week 24
Hide Description Change was calculated by subtracting screening 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 Screening, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post baseline insulin dose assessment during on-treatment period.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 151
Least Squares Mean (Standard Error)
Unit of Measure: units per day
-0.11  (0.442) -1.39  (0.458)
7.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 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 Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Missing data was imputed using LOCF. 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 up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 154 146
Measure Type: Number
Unit of Measure: percentage of participants
5.2 35.6
8.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 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 Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Missing data was imputed using LOCF. 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 up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 154 146
Measure Type: Number
Unit of Measure: percentage of participants
1.3 17.8
9.Secondary Outcome
Title Percentage of Patients Requiring Rescue Therapy During 24-Week Period
Hide Description Routine fasting 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 >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 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 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 up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 154
Measure Type: Number
Unit of Measure: percentage of participants
3.2 1.3
10.Other Pre-specified 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 the 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. 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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 142 131
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.14  (0.542) -7.09  (0.576)
11.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. 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.
Arm/Group Title Placebo Lixisenatide
Hide Arm/Group Description:
2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 150
Measure Type: Number
Unit of Measure: percentage of participants
4.5 7.3
12.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 less than 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 up to a maintenance dose of 20 mcg of volume matching placebo.
2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
Overall Number of Participants Analyzed 157 154
Measure Type: Number
Unit of Measure: participants
Symptomatic hypoglycemia 37 66
Severe symptomatic hypoglycemia 0 0
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 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 up to a maintenance dose of 20 mcg of volume matching placebo. 2-step initiation regimen up to a maintenance dose of 20 mcg 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   9/157 (5.73%)   10/154 (6.49%) 
Eye disorders     
Hyphaema * 1  1/157 (0.64%)  0/154 (0.00%) 
Retinal haemorrhage * 1  1/157 (0.64%)  0/154 (0.00%) 
Gastrointestinal disorders     
Colonic polyp * 1  1/157 (0.64%)  1/154 (0.65%) 
Nausea * 1  0/157 (0.00%)  1/154 (0.65%) 
Vomiting * 1  0/157 (0.00%)  1/154 (0.65%) 
Hepatobiliary disorders     
Liver disorder * 1  1/157 (0.64%)  0/154 (0.00%) 
Infections and infestations     
Herpes zoster oticus * 1  0/157 (0.00%)  1/154 (0.65%) 
Pneumonia * 1  1/157 (0.64%)  0/154 (0.00%) 
Upper respiratory tract infection * 1  0/157 (0.00%)  1/154 (0.65%) 
Injury, poisoning and procedural complications     
Cartilage injury * 1  0/157 (0.00%)  1/154 (0.65%) 
Hand fracture * 1  0/157 (0.00%)  1/154 (0.65%) 
Joint injury * 1  0/157 (0.00%)  1/154 (0.65%) 
Lower limb fracture * 1  1/157 (0.64%)  0/154 (0.00%) 
Skin laceration * 1  1/157 (0.64%)  0/154 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/157 (0.64%)  0/154 (0.00%) 
Rectal cancer * 1  1/157 (0.64%)  0/154 (0.00%) 
Nervous system disorders     
Cerebral infarction * 1  0/157 (0.00%)  2/154 (1.30%) 
Psychiatric disorders     
Completed suicide * 1  1/157 (0.64%)  0/154 (0.00%) 
Reproductive system and breast disorders     
Uterine prolapse * 1  0/157 (0.00%)  1/154 (0.65%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/157 (0.64%)  0/154 (0.00%) 
Nasal septum deviation * 1  1/157 (0.64%)  0/154 (0.00%) 
Vascular disorders     
Hypertensive crisis * 1  0/157 (0.00%)  1/154 (0.65%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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   71/157 (45.22%)   125/154 (81.17%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/157 (0.64%)  11/154 (7.14%) 
Constipation * 1  4/157 (2.55%)  8/154 (5.19%) 
Diarrhoea * 1  4/157 (2.55%)  10/154 (6.49%) 
Dyspepsia * 1  0/157 (0.00%)  11/154 (7.14%) 
Nausea * 1  7/157 (4.46%)  61/154 (39.61%) 
Vomiting * 1  3/157 (1.91%)  28/154 (18.18%) 
General disorders     
Asthenia * 1  12/157 (7.64%)  10/154 (6.49%) 
Infections and infestations     
Nasopharyngitis * 1  20/157 (12.74%)  21/154 (13.64%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  0/157 (0.00%)  10/154 (6.49%) 
Hypoglycaemia * 1 [1]  37/157 (23.57%)  67/154 (43.51%) 
Nervous system disorders     
Dizziness * 1  8/157 (5.10%)  13/154 (8.44%) 
Headache * 1  3/157 (1.91%)  16/154 (10.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
[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
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Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-us@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00866658     History of Changes
Other Study ID Numbers: EFC10887
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016