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Trial record 44 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT00715624
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : October 11, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Basal Insulin
Drug: Metformin
Device: Pen auto-injector
Enrollment 496
Recruitment Details The study was conducted at 111 centers in 15 countries between July 29, 2008 and February 8, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).
Pre-assignment Details A total of 879 patients were screened of which 383 (43.6%) 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 496 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 the end of treatment. 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 the end of treatment.
Period Title: Overall Study
Started 167 [1] 329
Treated/Safety Population 167 [2] 328
Modified Intent-to-Treat(mITT)Population 166 [3] 327
Completed 115 213
Not Completed 52 116
Reason Not Completed
Adverse Event             12             37
Lack of Efficacy             11             11
Lost to Follow-up             1             2
Protocol Violation             1             0
Withdrawal by Subject             11             25
Familial and personal reasons             10             22
Poor compliance             6             13
Sponsor decision             0             4
Incorrect randomization (not treated)             0             1
Other             0             1
[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 the end of treatment. 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 the end of treatment. Total of all reporting groups
Overall Number of Baseline Participants 167 328 495
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 167 participants 328 participants 495 participants
56.9  (9.8) 57.4  (9.5) 57.2  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 328 participants 495 participants
Female
85
  50.9%
182
  55.5%
267
  53.9%
Male
82
  49.1%
146
  44.5%
228
  46.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 328 participants 495 participants
Race: Caucasian/White 130 254 384
Race: Black 6 14 20
Race: Asian/Oriental 30 53 83
Race: Other 1 7 8
Ethnicity: Hispanic 40 94 134
Ethnicity: Non Hispanic 127 234 361
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 167 participants 328 participants 495 participants
8.37  (0.84) 8.42  (0.88) 8.40  (0.87)
2-Hour Postprandial Plasma Glucose (PPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 167 participants 328 participants 495 participants
16.11  (3.86) 16.47  (4.30) 16.35  (4.15)
[1]
Measure Description: The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 153 and 302 for Placebo and Lixisenatide treatment arms, respectively.
Average 7-Point Self Monitored Plasma Glucose (SMPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 167 participants 328 participants 495 participants
10.58  (2.69) 10.76  (2.61) 10.70  (2.64)
[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 analyzed = 155 and 301 for Placebo and Lixisenatide treatment arms, respectively.
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 167 participants 328 participants 495 participants
8.05  (2.65) 8.13  (2.83) 8.10  (2.76)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 167 participants 328 participants 495 participants
88.94  (20.84) 87.10  (20.01) 87.72  (20.29)
Total Insulin Dose  
Mean (Standard Deviation)
Unit of measure:  Units per day
Number Analyzed 167 participants 328 participants 495 participants
57.73  (34.54) 53.43  (33.89) 54.88  (34.14)
Glucose Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 167 participants 328 participants 495 participants
7.32  (3.43) 7.59  (3.60) 7.50  (3.54)
[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 = 153 and 301 for Placebo and Lixisenatide treatment arms, respectively.
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 328 participants 495 participants
12.43  (6.33) 12.48  (7.04) 12.46  (6.80)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 167 participants 328 participants 495 participants
32.56  (6.32) 31.91  (6.17) 32.13  (6.22)
[1]
Measure Description: BMI was calculated by dividing body weight by the height squared.
Basal Insulin Treatment Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 328 participants 495 participants
3.20  (3.96) 3.06  (3.37) 3.11  (3.57)
Number of Patients With Insulin Therapy at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 328 participants 495 participants
Glargine 83 165 248
Detemir 19 24 43
Neutral protamine hagedorn (NPH) 64 134 198
Premix (Mixed Insulin) 3 5 8
[1]
Measure Description: NPH included isophane insulin and insulin human injection, isophane. Premix insulin included Novolin 70/30 mix and Humalog 75/25 mix.
Number of Patients With Metformin use at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 328 participants 495 participants
Yes 131 261 392
No 36 67 103
Metformin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Milligram (mg) per day
Number Analyzed 167 participants 328 participants 495 participants
2008.02  (441.88) 1961.02  (459.07) 1976.72  (453.38)
[1]
Measure Description: Here, number of patients analyzed = 131 and 261 for Placebo and Lixisenatide treatment arm, respectively as only these participants received metformin.
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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. LOCF was 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 158 304
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.38  (0.107) -0.74  (0.090)
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, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) 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 0.0002
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%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.
Method ANCOVA
Comments To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.550 to -0.174
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.096
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 time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 123 235
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.72  (0.543) -5.54  (0.468)
3.Secondary Outcome
Title Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles 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 time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 7-point SMPG 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 153 294
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.61  (0.238) -1.49  (0.201)
4.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 time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 163 317
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.55  (0.281) -0.63  (0.233)
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 161 311
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
-0.52  (0.293) -1.80  (0.246)
6.Secondary Outcome
Title Change From Baseline in Total Insulin Dose at Week 24
Hide Description Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 total insulin dose 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 165 325
Least Squares Mean (Standard Error)
Unit of Measure: units per day
-1.93  (1.589) -5.62  (1.317)
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 158 304
Measure Type: Number
Unit of Measure: percentage of participants
12.0 28.3
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 158 304
Measure Type: Number
Unit of Measure: percentage of participants
3.8 14.5
9.Secondary Outcome
Title Percentage of Patients Requiring Rescue Therapy During Main 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 166 327
Measure Type: Number
Unit of Measure: percentage of participants
7.2 5.8
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 time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 123 233
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.34  (0.469) -4.14  (0.408)
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 161 311
Measure Type: Number
Unit of Measure: percentage of participants
3.1 13.2
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 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 for up to 125 weeks
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 167 328
Measure Type: Number
Unit of Measure: participants
Symptomatic hypoglycemia 65 138
Severe symptomatic hypoglycemia 1 7
Time Frame First dose of study drug up to 3 days after the last dose administration for up to 125 weeks
Adverse Event Reporting Description Median exposure to study treatment was 560 and 559 days in lixisenatide and placebo treatment arms, respectively. 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   17/167 (10.18%)   46/328 (14.02%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/167 (0.60%)  0/328 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * 1  2/167 (1.20%)  1/328 (0.30%) 
Angina pectoris * 1  2/167 (1.20%)  0/328 (0.00%) 
Atrial fibrillation * 1  1/167 (0.60%)  0/328 (0.00%) 
Atrial flutter * 1  0/167 (0.00%)  1/328 (0.30%) 
Coronary artery disease * 1  4/167 (2.40%)  2/328 (0.61%) 
Ischaemic cardiomyopathy * 1  1/167 (0.60%)  0/328 (0.00%) 
Left ventricular dysfunction * 1  0/167 (0.00%)  1/328 (0.30%) 
Myocardial infarction * 1  1/167 (0.60%)  1/328 (0.30%) 
Myocardial ischaemia * 1  1/167 (0.60%)  0/328 (0.00%) 
Pericardial effusion * 1  1/167 (0.60%)  0/328 (0.00%) 
Endocrine disorders     
Goitre * 1  0/167 (0.00%)  1/328 (0.30%) 
Eye disorders     
Cataract * 1  0/167 (0.00%)  1/328 (0.30%) 
Lens dislocation * 1  0/167 (0.00%)  1/328 (0.30%) 
Retinal haemorrhage * 1  0/167 (0.00%)  1/328 (0.30%) 
Retinopathy haemorrhagic * 1  0/167 (0.00%)  1/328 (0.30%) 
Gastrointestinal disorders     
Gastric ulcer * 1  0/167 (0.00%)  1/328 (0.30%) 
Pancreatitis * 1  0/167 (0.00%)  1/328 (0.30%) 
Upper gastrointestinal haemorrhage * 1  0/167 (0.00%)  1/328 (0.30%) 
General disorders     
Non-cardiac chest pain * 1  1/167 (0.60%)  4/328 (1.22%) 
Sudden cardiac death * 1  0/167 (0.00%)  1/328 (0.30%) 
Infections and infestations     
Anogenital warts * 1  0/167 (0.00%)  1/328 (0.30%) 
Bronchitis * 1  1/167 (0.60%)  0/328 (0.00%) 
Cellulitis * 1  0/167 (0.00%)  1/328 (0.30%) 
Coxsackie viral infection * 1  0/167 (0.00%)  1/328 (0.30%) 
Incision site cellulitis * 1  1/167 (0.60%)  0/328 (0.00%) 
Localised infection * 1  0/167 (0.00%)  1/328 (0.30%) 
Pharyngeal abscess * 1  0/167 (0.00%)  1/328 (0.30%) 
Pneumonia * 1  2/167 (1.20%)  3/328 (0.91%) 
Pneumonia viral * 1  0/167 (0.00%)  1/328 (0.30%) 
Pyelonephritis * 1  0/167 (0.00%)  1/328 (0.30%) 
Septic shock * 1  1/167 (0.60%)  0/328 (0.00%) 
Urinary tract infection * 1  0/167 (0.00%)  2/328 (0.61%) 
Injury, poisoning and procedural complications     
Procedural pain * 1  0/167 (0.00%)  1/328 (0.30%) 
Rib fracture * 1  0/167 (0.00%)  1/328 (0.30%) 
Spinal compression fracture * 1  0/167 (0.00%)  1/328 (0.30%) 
Wrist fracture * 1  1/167 (0.60%)  0/328 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/167 (0.60%)  1/328 (0.30%) 
Hypoglycaemic unconsciousness * 1  0/167 (0.00%)  1/328 (0.30%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  0/167 (0.00%)  1/328 (0.30%) 
Osteoarthritis * 1  0/167 (0.00%)  1/328 (0.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/167 (0.00%)  1/328 (0.30%) 
Cervix carcinoma * 1  0/167 (0.00%)  1/328 (0.30%) 
Glioma * 1  1/167 (0.60%)  0/328 (0.00%) 
Lung cancer metastatic * 1  0/167 (0.00%)  1/328 (0.30%) 
Lung neoplasm malignant * 1  0/167 (0.00%)  1/328 (0.30%) 
Pancreatic carcinoma * 1  0/167 (0.00%)  1/328 (0.30%) 
Prostate cancer * 1  1/167 (0.60%)  0/328 (0.00%) 
Renal cell carcinoma * 1  1/167 (0.60%)  0/328 (0.00%) 
Small cell lung cancer stage unspecified * 1  0/167 (0.00%)  1/328 (0.30%) 
Nervous system disorders     
Carotid artery stenosis * 1  0/167 (0.00%)  1/328 (0.30%) 
Intercostal neuralgia * 1  1/167 (0.60%)  0/328 (0.00%) 
Migraine * 1  0/167 (0.00%)  1/328 (0.30%) 
Presyncope * 1  0/167 (0.00%)  1/328 (0.30%) 
Somnolence * 1  0/167 (0.00%)  1/328 (0.30%) 
Transient ischaemic attack * 1  0/167 (0.00%)  1/328 (0.30%) 
Renal and urinary disorders     
Diabetic nephropathy * 1  1/167 (0.60%)  0/328 (0.00%) 
Renal failure * 1  1/167 (0.60%)  0/328 (0.00%) 
Urethral stenosis * 1  0/167 (0.00%)  1/328 (0.30%) 
Urinary bladder polyp * 1  0/167 (0.00%)  1/328 (0.30%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/167 (0.00%)  1/328 (0.30%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/167 (0.60%)  0/328 (0.00%) 
Respiratory failure * 1  1/167 (0.60%)  0/328 (0.00%) 
Skin and subcutaneous tissue disorders     
Neuropathic ulcer * 1  1/167 (0.60%)  0/328 (0.00%) 
Skin ulcer * 1  0/167 (0.00%)  1/328 (0.30%) 
Toxic skin eruption * 1  1/167 (0.60%)  0/328 (0.00%) 
Social circumstances     
Victim of crime * 1  1/167 (0.60%)  0/328 (0.00%) 
Surgical and medical procedures     
Coronary angioplasty * 1  2/167 (1.20%)  0/328 (0.00%) 
Coronary arterial stent insertion * 1  1/167 (0.60%)  0/328 (0.00%) 
Coronary artery bypass * 1  2/167 (1.20%)  1/328 (0.30%) 
Coronary revascularisation * 1  1/167 (0.60%)  0/328 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/167 (0.00%)  1/328 (0.30%) 
Leriche syndrome * 1  0/167 (0.00%)  1/328 (0.30%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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   104/167 (62.28%)   245/328 (74.70%) 
Gastrointestinal disorders     
Diarrhoea * 1  10/167 (5.99%)  37/328 (11.28%) 
Dyspepsia * 1  1/167 (0.60%)  17/328 (5.18%) 
Nausea * 1  16/167 (9.58%)  96/328 (29.27%) 
Vomiting * 1  2/167 (1.20%)  32/328 (9.76%) 
General disorders     
Asthenia * 1  10/167 (5.99%)  18/328 (5.49%) 
Infections and infestations     
Bronchitis * 1  13/167 (7.78%)  22/328 (6.71%) 
Influenza * 1  9/167 (5.39%)  28/328 (8.54%) 
Nasopharyngitis * 1  21/167 (12.57%)  32/328 (9.76%) 
Upper respiratory tract infection * 1  6/167 (3.59%)  24/328 (7.32%) 
Urinary tract infection * 1  6/167 (3.59%)  21/328 (6.40%) 
Investigations     
Blood glucose decreased * 1  7/167 (4.19%)  19/328 (5.79%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  68/167 (40.72%)  138/328 (42.07%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  11/167 (6.59%)  16/328 (4.88%) 
Back pain * 1  11/167 (6.59%)  24/328 (7.32%) 
Nervous system disorders     
Dizziness * 1  11/167 (6.59%)  26/328 (7.93%) 
Headache * 1  17/167 (10.18%)  41/328 (12.50%) 
Tremor * 1  6/167 (3.59%)  18/328 (5.49%) 
Vascular disorders     
Hypertension * 1  9/167 (5.39%)  17/328 (5.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT00715624     History of Changes
Other Study ID Numbers: EFC6016
2007-005886-36 ( EudraCT Number )
First Submitted: July 11, 2008
First Posted: July 15, 2008
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: November 28, 2016