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Trial record 41 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT00763815
Recruitment Status : Completed
First Posted : October 1, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus Type 2
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Pioglitazone
Drug: Metformin
Enrollment 484
Recruitment Details The study was conducted at 150 centers in 13 countries between September 29, 2008 and June 29, 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 906 patients were screened of which 422 (46.6%) 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 484 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 161 [1] 323
Treated/Safety Population 161 [2] 323
Modified Intent-to-Treat(mITT)Population 159 [3] 320
Completed 109 239
Not Completed 52 84
Reason Not Completed
Adverse Event             14             29
Lack of Efficacy             10             11
Poor Compliance to Protocol             6             6
Lost to Follow-up             2             4
Early Termination             1             0
Familial and Personal Reasons             9             16
Physician Decision             1             0
Withdrawal by Subject             7             12
Protocol Violation             2             5
Sponsor's Decision             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 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. Total of all reporting groups
Overall Number of Baseline Participants 161 323 484
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 161 participants 323 participants 484 participants
55.3  (9.5) 56.0  (9.5) 55.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 323 participants 484 participants
Female
79
  49.1%
151
  46.7%
230
  47.5%
Male
82
  50.9%
172
  53.3%
254
  52.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 323 participants 484 participants
Race: Caucasian/White 132 273 405
Race: Black 9 14 23
Race: Asian/Oriental 8 14 22
Race: Other 12 22 34
Ethnicity: Hispanic 41 87 128
Ethnicity: Non Hispanic 120 236 356
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 161 participants 323 participants 484 participants
8.06  (0.79) 8.08  (0.90) 8.07  (0.86)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 161 participants 323 participants 484 participants
9.13  (2.20) 9.11  (2.15) 9.12  (2.16)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 161 participants 323 participants 484 participants
96.74  (25.58) 92.93  (22.90) 94.20  (23.87)
Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of normal beta cells function
Number Analyzed 161 participants 323 participants 484 participants
36.23  (26.50) 34.69  (30.30) 35.18  (29.12)
[1]
Measure Description: Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Here, Number of patients analyzed = 141 and 300 for Placebo and Lixisenatide treatment arms, respectively.
Fasting Plasma Insulin (FPI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Picomole per liter (pmol/L)
Number Analyzed 161 participants 323 participants 484 participants
66.07  (48.12) 63.32  (57.69) 64.21  (54.76)
[1]
Measure Description: Here, Number of patients analyzed = 142 and 300 for Placebo and Lixisenatide treatment arms, respectively.
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 323 participants 484 participants
8.09  (5.58) 8.11  (5.44) 8.10  (5.48)
Duration of Pioglitazone Treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 323 participants 484 participants
1.79  (2.51) 1.69  (2.00) 1.72  (2.18)
Pioglitazone Daily Dose  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 323 participants 484 participants
>=30 milligram (mg) to Less Than (<) 45 mg 126 242 368
>= 45 mg 35 81 116
Metformin Use at Screening   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 323 participants 484 participants
131 261 392
[1]
Measure Description: Number of patients with metformin use at baseline was reported.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 161 participants 323 participants 484 participants
34.44  (7.04) 33.66  (6.71) 33.92  (6.82)
[1]
Measure Description: BMI was calculated by dividing body weight (kilogram) by the height (meter) squared.
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. 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 of volume matching placebo.
2-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 148 308
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.34  (0.100) -0.90  (0.089)
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 patients 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 <0.0001
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%), metformin 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 -0.56
Confidence Interval (2-Sided) 95%
-0.731 to -0.386
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.088
Estimation Comments [Not Specified]
2.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 last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.
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 159 317
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.32  (0.215) -1.16  (0.192)
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 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 157 315
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
0.21  (0.357) -0.21  (0.324)
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Insulin (FPI) 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 FPI 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 125 281
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-1.01  (4.080) -10.36  (3.397)
5.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. 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 148 308
Measure Type: Number
Unit of Measure: percentage of participants
26.4 52.3
6.Secondary Outcome
Title Percentage of Patients With 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. 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 148 308
Measure Type: Number
Unit of Measure: percentage of participants
10.1 28.9
7.Secondary Outcome
Title Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24
Hide Description Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). 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 HOMA-beta 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 124 281
Least Squares Mean (Standard Error)
Unit of Measure: % of normal beta cells function
6.98  (3.575) 6.72  (2.963)
8.Secondary Outcome
Title Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
Hide Description Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >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 159 320
Measure Type: Number
Unit of Measure: percentage of participants
11.3 3.8
9.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 157 315
Measure Type: Number
Unit of Measure: percentage of participants
5.1 9.2
10.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 132 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 161 323
Measure Type: Number
Unit of Measure: participants
Symptomatic Hypoglycemia 7 23
Severe Symptomatic Hypoglycemia 0 0
Time Frame First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks
Adverse Event Reporting Description Median exposure to study treatment was 615.5 and 588.0 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   15/161 (9.32%)   25/323 (7.74%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/161 (0.00%)  1/323 (0.31%) 
Acute myocardial infarction * 1  1/161 (0.62%)  0/323 (0.00%) 
Angina unstable * 1  1/161 (0.62%)  0/323 (0.00%) 
Arteriosclerosis coronary artery * 1  0/161 (0.00%)  1/323 (0.31%) 
Coronary artery disease * 1  1/161 (0.62%)  1/323 (0.31%) 
Mitral valve incompetence * 1  1/161 (0.62%)  0/323 (0.00%) 
Eye disorders     
Diabetic retinopathy * 1  0/161 (0.00%)  1/323 (0.31%) 
Macular oedema * 1  0/161 (0.00%)  1/323 (0.31%) 
Retinal detachment * 1  0/161 (0.00%)  1/323 (0.31%) 
Vitreous haemorrhage * 1  0/161 (0.00%)  1/323 (0.31%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/161 (0.62%)  0/323 (0.00%) 
Peritoneal haemorrhage * 1  0/161 (0.00%)  1/323 (0.31%) 
Umbilical hernia * 1  0/161 (0.00%)  2/323 (0.62%) 
General disorders     
Non-cardiac chest pain * 1  0/161 (0.00%)  3/323 (0.93%) 
Hepatobiliary disorders     
Cholecystitis chronic * 1  0/161 (0.00%)  1/323 (0.31%) 
Infections and infestations     
Appendicitis * 1  0/161 (0.00%)  1/323 (0.31%) 
Bronchitis * 1  1/161 (0.62%)  1/323 (0.31%) 
Cellulitis * 1  1/161 (0.62%)  0/323 (0.00%) 
Diabetic foot infection * 1  0/161 (0.00%)  1/323 (0.31%) 
Pneumonia * 1  2/161 (1.24%)  1/323 (0.31%) 
Urinary tract infection * 1  0/161 (0.00%)  1/323 (0.31%) 
Injury, poisoning and procedural complications     
Abdominal injury * 1  0/161 (0.00%)  1/323 (0.31%) 
Foot fracture * 1  0/161 (0.00%)  1/323 (0.31%) 
Injury * 1  0/161 (0.00%)  1/323 (0.31%) 
Meniscus lesion * 1  1/161 (0.62%)  0/323 (0.00%) 
Multiple fractures * 1  0/161 (0.00%)  1/323 (0.31%) 
Investigations     
Blood calcitonin increased * 1  1/161 (0.62%)  0/323 (0.00%) 
Colonoscopy * 1  1/161 (0.62%)  0/323 (0.00%) 
Weight decreased * 1  1/161 (0.62%)  0/323 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  1/161 (0.62%)  0/323 (0.00%) 
Musculoskeletal and connective tissue disorders     
Gouty arthritis * 1  0/161 (0.00%)  1/323 (0.31%) 
Neuropathic arthropathy * 1  0/161 (0.00%)  1/323 (0.31%) 
Osteoarthritis * 1  0/161 (0.00%)  1/323 (0.31%) 
Spinal column stenosis * 1  1/161 (0.62%)  0/323 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer * 1  1/161 (0.62%)  0/323 (0.00%) 
Non-small cell lung cancer * 1  0/161 (0.00%)  1/323 (0.31%) 
Nervous system disorders     
Cerebral infarction * 1  0/161 (0.00%)  1/323 (0.31%) 
Convulsion * 1  0/161 (0.00%)  1/323 (0.31%) 
Memory impairment * 1  1/161 (0.62%)  0/323 (0.00%) 
Sciatica * 1  0/161 (0.00%)  1/323 (0.31%) 
Transient ischaemic attack * 1  0/161 (0.00%)  1/323 (0.31%) 
Renal and urinary disorders     
Stag horn calculus * 1  0/161 (0.00%)  1/323 (0.31%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  0/161 (0.00%)  1/323 (0.31%) 
Pneumonitis * 1  1/161 (0.62%)  0/323 (0.00%) 
Surgical and medical procedures     
Coronary angioplasty * 1  0/161 (0.00%)  1/323 (0.31%) 
Coronary artery bypass * 1  2/161 (1.24%)  0/323 (0.00%) 
Percutaneous coronary intervention * 1  0/161 (0.00%)  1/323 (0.31%) 
Vascular disorders     
Blue toe syndrome * 1  0/161 (0.00%)  1/323 (0.31%) 
Shock haemorrhagic * 1  0/161 (0.00%)  1/323 (0.31%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
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   105/161 (65.22%)   219/323 (67.80%) 
Gastrointestinal disorders     
Diarrhoea * 1  23/161 (14.29%)  35/323 (10.84%) 
Nausea * 1  22/161 (13.66%)  84/323 (26.01%) 
Vomiting * 1  8/161 (4.97%)  26/323 (8.05%) 
General disorders     
Fatigue * 1  3/161 (1.86%)  21/323 (6.50%) 
Oedema peripheral * 1  9/161 (5.59%)  17/323 (5.26%) 
Infections and infestations     
Bronchitis * 1  16/161 (9.94%)  25/323 (7.74%) 
Influenza * 1  9/161 (5.59%)  24/323 (7.43%) 
Nasopharyngitis * 1  24/161 (14.91%)  53/323 (16.41%) 
Upper respiratory tract infection * 1  18/161 (11.18%)  41/323 (12.69%) 
Urinary tract infection * 1  11/161 (6.83%)  24/323 (7.43%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1 [1]  8/161 (4.97%)  25/323 (7.74%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  11/161 (6.83%)  24/323 (7.43%) 
Back pain * 1  14/161 (8.70%)  22/323 (6.81%) 
Nervous system disorders     
Dizziness * 1  13/161 (8.07%)  33/323 (10.22%) 
Headache * 1  19/161 (11.80%)  43/323 (13.31%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  11/161 (6.83%)  18/323 (5.57%) 
Vascular disorders     
Hypertension * 1  9/161 (5.59%)  17/323 (5.26%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
[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
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-us@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00763815     History of Changes
Other Study ID Numbers: EFC6017
EudraCT: 2007-005884-92
First Submitted: September 30, 2008
First Posted: October 1, 2008
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: November 28, 2016