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Trial record 42 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT00707031
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : October 11, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Lixisenatide (AVE0010)
Device: Pen auto-injector
Drug: Exenatide
Device: Prefilled pen injector
Drug: Metformin
Enrollment 639
Recruitment Details The study was conducted at 122 centers in 18 countries between June 23, 2008 and November 18, 2010. The overall duration of treatment was at least 76 weeks (24 weeks main open-label treatment; variable open-label extension treatment).
Pre-assignment Details A total of 1243 patients were screened of which 604 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 639 patients were randomized.
Arm/Group Title Lixisenatide Exenatide
Hide Arm/Group Description 2-step initiation regimen of lixisenatide: 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. 1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
Period Title: Overall Study
Started 320 [1] 319
Treated/Safety Population 318 [2] 316
Modified Intent-to-Treat Population 315 [3] 315
Completed 216 220
Not Completed 104 99
Reason Not Completed
Adverse Event             45             45
Lack of Efficacy             19             6
Lost to Follow-up             2             1
Protocol Violation             1             0
Withdrawal by Subject             7             8
Poor Compliance to Protocol             7             13
Familial or Personal Reasons             12             15
Serious Noncompliance             2             3
Sponsor Decision             9             8
[1]
Randomized
[2]
All patients who received 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 Lixisenatide Exenatide Total
Hide Arm/Group Description 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. 1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment. Total of all reporting groups
Overall Number of Baseline Participants 318 316 634
Hide Baseline Analysis Population Description
Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered. In addition, 5 patients from one site with serious noncompliance issues were excluded from all analysis populations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 318 participants 316 participants 634 participants
57.3  (9.2) 57.6  (10.7) 57.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 318 participants 316 participants 634 participants
Female
167
  52.5%
129
  40.8%
296
  46.7%
Male
151
  47.5%
187
  59.2%
338
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 318 participants 316 participants 634 participants
Race: Caucasian/White 296 292 588
Race: Black 8 10 18
Race: Asian/Oriental 3 4 7
Race: Other 11 10 21
Ethnicity: Hispanic 87 83 170
Ethnicity: Non Hispanic 231 233 464
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 318 participants 316 participants 634 participants
7.95  (0.81) 7.97  (0.78) 7.96  (0.80)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 318 participants 316 participants 634 participants
9.7  (2.0) 9.7  (2.3) 9.7  (2.1)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 318 participants 316 participants 634 participants
94.0  (19.6) 96.1  (22.5) 95.0  (21.13)
Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 318 participants 316 participants 634 participants
0.59  (0.7) 0.56  (0.7) 0.58  (0.7)
[1]
Measure Description: A 30-item self-administered questionnaire to measure health related quality of life (QOL) of patients with upper gastrointestinal disorders during past 2 weeks; consisted of 5 dimensions (subscales). Each item rated on a 0-5 point Likert scale, where 0=none of the time and 5=all the time. Subscale score was calculated by dividing sum of all items of subscale by number of items in subscale. Total score was calculated by taking the mean of subscale scores. Subscale score and total score range from 0 to 5 with lower scores indicating better quality of life.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 318 participants 316 participants 634 participants
33.68  (6.27) 33.51  (6.54) 33.60  (6.40)
[1]
Measure Description: BMI was calculated by dividing body weight by the height squared.
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 318 participants 316 participants 634 participants
6.78  (5.54) 6.75  (4.87) 6.76  (5.21)
Daily Metformin Dose  
Mean (Standard Deviation)
Unit of measure:  Milligram (mg)
Number Analyzed 318 participants 316 participants 634 participants
2020.20  (459.41) 2058.39  (453.23) 2039.24  (456.38)
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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 295 297
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.79  (0.053) -0.96  (0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Exenatide
Comments To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was <=0.4%.
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.033 to 0.297
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.067
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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 310 301
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.22  (0.116) -1.45  (0.119)
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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 295 296
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
-2.96  (0.231) -3.98  (0.232)
4.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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 295 297
Measure Type: Number
Unit of Measure: percentage of participants
48.5 49.8
5.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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 295 297
Measure Type: Number
Unit of Measure: percentage of participants
28.5 35.4
6.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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 315 315
Measure Type: Number
Unit of Measure: percentage of participants
2.2 3.8
7.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 11 (Week 24) or Day 169 if Visit 11 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 Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
2-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 295 296
Measure Type: Number
Unit of Measure: percentage of participants
25.1 31.4
8.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 an event with clinical symptoms that were considered to result from hypoglycemia 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 116 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.
Arm/Group Title Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
2-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 318 316
Measure Type: Number
Unit of Measure: participants
Symptomatic Hypoglycemia 16 46
Severe Symptomatic Hypoglycemia 0 0
9.Other Pre-specified Outcome
Title Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24
Hide Description PAGI-QOL: a 30–item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this 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 11 (Week 24) or Day 169 if Visit 11 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 PAGI-QOL assessment during on-treatment period.
Arm/Group Title Lixisenatide Exenatide
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of exenatide.
Overall Number of Participants Analyzed 302 292
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.09  (0.031) -0.06  (0.032)
Time Frame First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks
Adverse Event Reporting Description Median exposure to study treatment was 562 and 560 days in lixisenatide and exenatide 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 Lixisenatide Exenatide
Hide Arm/Group Description 2-step initiation regimen of lixisenatide. 1-step initiation regimen of exenatide.
All-Cause Mortality
Lixisenatide Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   26/318 (8.18%)   22/316 (6.96%) 
Cardiac disorders     
Acute myocardial infarction * 1  0/318 (0.00%)  1/316 (0.32%) 
Arrhythmia * 1  1/318 (0.31%)  0/316 (0.00%) 
Atrial fibrillation * 1  1/318 (0.31%)  1/316 (0.32%) 
Myocardial infarction * 1  0/318 (0.00%)  1/316 (0.32%) 
Myocardial ischaemia * 1  1/318 (0.31%)  0/316 (0.00%) 
Eye disorders     
Retinopathy * 1  1/318 (0.31%)  0/316 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia * 1  1/318 (0.31%)  0/316 (0.00%) 
Haemorrhoids * 1  1/318 (0.31%)  0/316 (0.00%) 
Inguinal hernia * 1  1/318 (0.31%)  0/316 (0.00%) 
General disorders     
Non-cardiac chest pain * 1  1/318 (0.31%)  1/316 (0.32%) 
Pain * 1  0/318 (0.00%)  1/316 (0.32%) 
Pyrexia * 1  1/318 (0.31%)  0/316 (0.00%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/318 (0.00%)  1/316 (0.32%) 
Cholecystitis acute * 1  1/318 (0.31%)  0/316 (0.00%) 
Cholecystitis chronic * 1  0/318 (0.00%)  1/316 (0.32%) 
Infections and infestations     
Appendicitis * 1  1/318 (0.31%)  1/316 (0.32%) 
Bronchitis * 1  1/318 (0.31%)  0/316 (0.00%) 
Cellulitis * 1  0/318 (0.00%)  1/316 (0.32%) 
Pneumonia * 1  1/318 (0.31%)  0/316 (0.00%) 
Pneumonia bacterial * 1  0/318 (0.00%)  1/316 (0.32%) 
Pyelonephritis acute * 1  1/318 (0.31%)  0/316 (0.00%) 
Sepsis * 1  2/318 (0.63%)  0/316 (0.00%) 
Septic shock * 1  0/318 (0.00%)  1/316 (0.32%) 
Upper respiratory tract infection * 1  1/318 (0.31%)  0/316 (0.00%) 
Urosepsis * 1  0/318 (0.00%)  1/316 (0.32%) 
Injury, poisoning and procedural complications     
Intentional overdose * 1  0/318 (0.00%)  1/316 (0.32%) 
Tendon rupture * 1  1/318 (0.31%)  0/316 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  0/318 (0.00%)  1/316 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign lung neoplasm * 1  1/318 (0.31%)  0/316 (0.00%) 
Gastrointestinal stromal tumour * 1  1/318 (0.31%)  0/316 (0.00%) 
Metastatic neoplasm * 1  1/318 (0.31%)  0/316 (0.00%) 
Pancreatic carcinoma * 1  0/318 (0.00%)  1/316 (0.32%) 
Prostate cancer * 1  0/318 (0.00%)  1/316 (0.32%) 
Thyroid cancer * 1  0/318 (0.00%)  1/316 (0.32%) 
Nervous system disorders     
Carotid artery stenosis * 1  1/318 (0.31%)  0/316 (0.00%) 
Cognitive disorder * 1  0/318 (0.00%)  1/316 (0.32%) 
Facial paresis * 1  0/318 (0.00%)  1/316 (0.32%) 
Loss of consciousness * 1  0/318 (0.00%)  1/316 (0.32%) 
Sciatica * 1  1/318 (0.31%)  0/316 (0.00%) 
Syncope * 1  1/318 (0.31%)  1/316 (0.32%) 
Psychiatric disorders     
Anxiety * 1  1/318 (0.31%)  0/316 (0.00%) 
Suicide attempt * 1  0/318 (0.00%)  1/316 (0.32%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/318 (0.00%)  1/316 (0.32%) 
Prostatitis * 1  0/318 (0.00%)  1/316 (0.32%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  1/318 (0.31%)  0/316 (0.00%) 
Vascular disorders     
Haematoma * 1  1/318 (0.31%)  0/316 (0.00%) 
Hypotension * 1  0/318 (0.00%)  2/316 (0.63%) 
Subclavian artery stenosis * 1  1/318 (0.31%)  0/316 (0.00%) 
*
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%
Lixisenatide Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   204/318 (64.15%)   218/316 (68.99%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  16/318 (5.03%)  14/316 (4.43%) 
Constipation * 1  14/318 (4.40%)  17/316 (5.38%) 
Diarrhoea * 1  48/318 (15.09%)  54/316 (17.09%) 
Dyspepsia * 1  19/318 (5.97%)  21/316 (6.65%) 
Nausea * 1  91/318 (28.62%)  119/316 (37.66%) 
Vomiting * 1  41/318 (12.89%)  49/316 (15.51%) 
General disorders     
Fatigue * 1  16/318 (5.03%)  9/316 (2.85%) 
Infections and infestations     
Bronchitis * 1  19/318 (5.97%)  19/316 (6.01%) 
Influenza * 1  29/318 (9.12%)  32/316 (10.13%) 
Nasopharyngitis * 1  49/318 (15.41%)  35/316 (11.08%) 
Upper respiratory tract infection * 1  18/318 (5.66%)  13/316 (4.11%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1 [1]  18/318 (5.66%)  48/316 (15.19%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  19/318 (5.97%)  13/316 (4.11%) 
Back pain * 1  19/318 (5.97%)  16/316 (5.06%) 
Nervous system disorders     
Dizziness * 1  21/318 (6.60%)  31/316 (9.81%) 
Headache * 1  46/318 (14.47%)  31/316 (9.81%) 
Vascular disorders     
Hypertension * 1  19/318 (5.97%)  10/316 (3.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
[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
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00707031     History of Changes
Other Study ID Numbers: EFC6019
2007-005883-28 ( EudraCT Number )
First Submitted: June 26, 2008
First Posted: June 30, 2008
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: December 2, 2016