Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 61 for:    Lixisenatide

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01517412
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : October 14, 2016
Last Update Posted : October 14, 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 Type 2 Diabetes Mellitus
Interventions Drug: Lixisenatide (AVE0010)
Device: Self-injector pen device (OptiClik®)
Drug: Metformin
Enrollment 451
Recruitment Details The study was conducted at 82 centers in 10 countries. A total of 734 participants were screened between February 15, 2012 and October 16, 2012. 283 participants were screen failures; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of protocol defined range. 451 participants were randomized.
Pre-assignment Details Participants were stratified according to main meal of day (breakfast, lunch or dinner) and screening values of HbA1c (<8% or ≥8%).
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Period Title: Overall Study
Started 225 226
Completed 189 202
Not Completed 36 24
Reason Not Completed
Adverse Event             10             11
Lack of Efficacy             10             5
Poor compliance to protocol             8             3
Other than specified above             8             5
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast Total
Hide Arm/Group Description Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. Total of all reporting groups
Overall Number of Baseline Participants 225 226 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 226 participants 451 participants
56.3  (10.6) 57.5  (9.7) 56.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 226 participants 451 participants
Female
124
  55.1%
129
  57.1%
253
  56.1%
Male
101
  44.9%
97
  42.9%
198
  43.9%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 226 participants 451 participants
Caucasian/White 211 211 422
Black 4 8 12
Asian/Oriental 10 7 17
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 226 participants 451 participants
Hispanic 11 12 23
Non-Hispanic 214 214 428
Number of Participants with Categorical Body Mass Index (BMI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 226 participants 451 participants
<30 kg/m^2 51 60 111
≥30 kg/m^2 174 166 340
BMI, Continuous  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 225 participants 226 participants 451 participants
33.47  (4.50) 32.77  (4.62) 33.12  (4.57)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 225 participants 226 participants 451 participants
7.85  (0.76) 7.93  (0.78) 7.89  (0.77)
Fasting Plasma Glucose (FPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 225 participants 226 participants 451 participants
9.22  (2.03) 9.31  (2.04) 9.26  (2.03)
[1]
Measure Description: N=225, 225
Average 7-point Self-monitored Plasma Glucose (SMPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 225 participants 226 participants 451 participants
9.41  (2.01) 9.71  (2.13) 9.56  (2.07)
[1]
Measure Description: N=211, 207
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 226 participants 451 participants
6.69  (4.92) 7.78  (5.56) 7.24  (5.27)
Metformin Daily Dose  
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 225 participants 226 participants 451 participants
2040.7  (390.0) 2091.2  (1255.3) 2066.0  (929.6)
Randomization Strata of Main Meal of the Day  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 226 participants 451 participants
Breakfast 20 20 40
Lunch 116 117 233
Dinner 89 89 178
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 24
Hide Description Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 222
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of hemoglobin
-0.65  (0.074) -0.74  (0.074)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide Main Meal, Lixisenatide Breakfast
Comments Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.067 to 0.242
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.079
Estimation Comments Lixisenatide Main Meal vs Lixisenatide Breakfast
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lixisenatide Main Meal, Lixisenatide Breakfast
Comments Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2664
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.079
Estimation Comments Lixisenatide Main Meal vs Lixisenatide Breakfast
2.Secondary Outcome
Title Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24
Hide Description Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 222
Measure Type: Number
Unit of Measure: Percentage of participants
HbA1c <7% 43.6 42.8
HbA1c ≤6.5% 22.5 25.7
3.Secondary Outcome
Title Change in Average 7-point SMPG Profiles From Baseline to Week 24
Hide Description Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 202 200
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.80  (0.145) -1.10  (0.145)
4.Secondary Outcome
Title Change in FPG From Baseline to Week 24
Hide Description Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 220 222
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.35  (0.192) -0.57  (0.193)
5.Secondary Outcome
Title Change in Body Weight From Baseline to Week 24
Hide Description Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 220 224
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.60  (0.320) -2.80  (0.319)
6.Secondary Outcome
Title Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period
Hide Description Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 222
Measure Type: Number
Unit of Measure: Percentage of participants
40.4 41.0
7.Secondary Outcome
Title Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24
Hide Description Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 223
Measure Type: Number
Unit of Measure: Percentage of participants
40.8 38.6
8.Secondary Outcome
Title Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period
Hide Description Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 223
Measure Type: Number
Unit of Measure: Percentage of participants
38.1 37.2
9.Secondary Outcome
Title Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24
Hide Description On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 218 221
Measure Type: Number
Unit of Measure: Percentage of participants
28.9 27.6
10.Secondary Outcome
Title Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24
Hide Description DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description:
Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
Overall Number of Participants Analyzed 204 215
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.01  (0.546) 3.54  (0.529)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug). Safety population defined as all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Lixisenatide Main Meal Lixisenatide Breakfast
Hide Arm/Group Description Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin. Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
All-Cause Mortality
Lixisenatide Main Meal Lixisenatide Breakfast
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide Main Meal Lixisenatide Breakfast
Affected / at Risk (%) Affected / at Risk (%)
Total   7/225 (3.11%)   7/226 (3.10%) 
Cardiac disorders     
Myocardial infarction  1  1/225 (0.44%)  0/226 (0.00%) 
Atrial fibrillation  1  0/225 (0.00%)  1/226 (0.44%) 
Gastrointestinal disorders     
Abdominal hernia  1  0/225 (0.00%)  1/226 (0.44%) 
Abdominal strangulated hernia  1  0/225 (0.00%)  1/226 (0.44%) 
Infections and infestations     
Cellulitis  1  1/225 (0.44%)  0/226 (0.00%) 
Postoperative wound infection  1  0/225 (0.00%)  1/226 (0.44%) 
Injury, poisoning and procedural complications     
Contusion  1  0/225 (0.00%)  1/226 (0.44%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/225 (0.00%)  1/226 (0.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Clear cell renal cell carcinoma  1  1/225 (0.44%)  0/226 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  0/225 (0.00%)  1/226 (0.44%) 
Renal and urinary disorders     
Renal colic  1  2/225 (0.89%)  0/226 (0.00%) 
Cystitis noninfective  1  1/225 (0.44%)  0/226 (0.00%) 
Calculus ureteric  1  0/225 (0.00%)  1/226 (0.44%) 
Vascular disorders     
Peripheral arterial occlusive disease  1  1/225 (0.44%)  0/226 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lixisenatide Main Meal Lixisenatide Breakfast
Affected / at Risk (%) Affected / at Risk (%)
Total   65/225 (28.89%)   60/226 (26.55%) 
Gastrointestinal disorders     
Nausea  1  33/225 (14.67%)  35/226 (15.49%) 
Infections and infestations     
Nasopharyngitis  1  22/225 (9.78%)  16/226 (7.08%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  15/225 (6.67%)  7/226 (3.10%) 
Nervous system disorders     
Headache  1  8/225 (3.56%)  16/226 (7.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01517412     History of Changes
Other Study ID Numbers: EFC12261
2011-002416-85 ( EudraCT Number )
U1111-1118-0841 ( Other Identifier: UTN )
First Submitted: January 16, 2012
First Posted: January 25, 2012
Results First Submitted: August 22, 2016
Results First Posted: October 14, 2016
Last Update Posted: October 14, 2016