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Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (GetGoal-M-Asia)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01169779
First received: July 23, 2010
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Metformin
Drug: Sulfonylurea

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 35 centers in 4 countries between July 21, 2010 and December 22, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 655 patients were screened of which 264 (40.3%) 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 391 patients were randomized.

Reporting Groups
  Description
Placebo 1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
Lixisenatide 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.

Participant Flow:   Overall Study
    Placebo   Lixisenatide
STARTED   195 [1]   196 
Treated/Safety Population   194 [2]   196 
Modified Intent-to-Treat(mITT)Population   193 [3]   195 
Subgroup for Standardized Meal Test   130 [4]   121 
COMPLETED   184   179 
NOT COMPLETED   11   17 
Adverse Event                3                11 
Lack of Efficacy                1                0 
Protocol Violation                1                1 
Withdrawal by Subject                3                2 
Familial and personal reasons                3                3 
[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.
[4] Patients at selected sites where standardized meal test was performed.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.

Reporting Groups
  Description
Placebo 1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
Lixisenatide 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
Total Total of all reporting groups

Baseline Measures
   Placebo   Lixisenatide   Total 
Overall Participants Analyzed 
[Units: Participants]
 194   196   390 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (10.5)   54.5  (10.3)   54.8  (10.4) 
Gender 
[Units: Participants]
     
Female   103   95   198 
Male   91   101   192 
Race/Ethnicity, Customized 
[Units: Participants]
     
Race: Asian/Oriental   194   196   390 
Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 7.85  (0.71)   7.95  (0.81)   7.90  (0.76) 
Fasting Plasma Glucose (FPG) 
[Units: Millimole per liter (mmol/L)]
Mean (Standard Deviation)
 8.74  (1.83)   8.84  (2.12)   8.79  (1.98) 
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 17.19  (4.06)   16.07  (3.77)   16.65  (3.95) 
[1] The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 130 and 121 for Placebo and Lixisenatide treatment arm, respectively, as meal challenge test was performed at selected sites only.
Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 8.14  (3.11)   7.12  (3.21)   7.65  (3.20) 
[1] Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients analyzed = 130 and 121 for Placebo and Lixisenatide treatment arm, respectively, as meal challenge test was performed at selected sites only.
Body Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 72.74  (13.64)   73.18  (13.93)   72.96  (13.77) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 6.84  (4.80)   6.45  (4.64)   6.64  (4.72) 
Body Mass Index (BMI) [1] 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 27.08  (3.75)   26.75  (3.86)   26.91  (3.80) 
[1] BMI was calculated by dividing body weight by the height squared.
Metformin Daily Dose 
[Units: Milligram (mg) per day]
Mean (Standard Deviation)
 1363.4  (221.9)   1369.9  (219.9)   1366.7  (220.7) 
Number of Patients With Sulfonylurea use at Baseline 
[Units: Participants]
     
Yes   92   82   174 
No   102   114   216 


  Outcome Measures
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1.  Primary:   Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Change From Baseline in Body Weight at Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Change From Baseline in Glucose Excursion at Week 24   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:   Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period   [ Time Frame: Baseline up to Week 24 ]

9.  Other Pre-specified:   Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

10.  Other Pre-specified:   Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-us@sanofi.com


Publications of Results:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01169779     History of Changes
Other Study ID Numbers: EFC11321
U1111-1116-8938 ( Other Identifier: UTN )
Study First Received: July 23, 2010
Results First Received: August 18, 2016
Last Updated: August 18, 2016
Health Authority: China: Ethics Committee