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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01517412
First received: January 16, 2012
Last updated: August 22, 2016
Last verified: August 2016
Results First Received: August 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Lixisenatide (AVE0010)
Device: Self-injector pen device (OptiClik®)
Drug: Metformin

  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 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified according to main meal of day (breakfast, lunch or dinner) and screening values of HbA1c (<8% or ≥8%).

Reporting Groups
  Description
Lixisenatide Main Meal 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 Breakfast 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.

Participant Flow:   Overall Study
    Lixisenatide Main Meal   Lixisenatide Breakfast
STARTED   225   226 
COMPLETED   189   202 
NOT COMPLETED   36   24 
Adverse Event                10                11 
Lack of Efficacy                10                5 
Poor compliance to protocol                8                3 
Other than specified above                8                5 



  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.
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Reporting Groups
  Description
Lixisenatide Main Meal 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 Breakfast 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 Total of all reporting groups

Baseline Measures
    Lixisenatide Main Meal   Lixisenatide Breakfast   Total
Overall Participants Analyzed 
[Units: Participants]
 225   226   451 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.3  (10.6)   57.5  (9.7)   56.9  (10.2) 
Gender 
[Units: Participants]
     
Female   124   129   253 
Male   101   97   198 
Race 
[Units: Participants]
     
Caucasian/White   211   211   422 
Black   4   8   12 
Asian/Oriental   10   7   17 
Ethnicity 
[Units: Participants]
     
Hispanic   11   12   23 
Non-Hispanic   214   214   428 
Number of Participants with Categorical Body Mass Index (BMI) 
[Units: Participants]
     
<30 kg/m^2   51   60   111 
≥30 kg/m^2   174   166   340 
BMI, Continuous 
[Units: Kg/m^2]
Mean (Standard Deviation)
 33.47  (4.50)   32.77  (4.62)   33.12  (4.57) 
HbA1c 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 7.85  (0.76)   7.93  (0.78)   7.89  (0.77) 
Fasting Plasma Glucose (FPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 9.22  (2.03)   9.31  (2.04)   9.26  (2.03) 
[1] N=225, 225
Average 7-point Self-monitored Plasma Glucose (SMPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 9.41  (2.01)   9.71  (2.13)   9.56  (2.07) 
[1] N=211, 207
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 6.69  (4.92)   7.78  (5.56)   7.24  (5.27) 
Metformin Daily Dose 
[Units: Mg]
Mean (Standard Deviation)
 2040.7  (390.0)   2091.2  (1255.3)   2066.0  (929.6) 
Randomization Strata of Main Meal of the Day 
[Units: Participants]
     
Breakfast   20   20   40 
Lunch   116   117   233 
Dinner   89   89   178 


  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change in Average 7-point SMPG Profiles From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Change in FPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

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

6.  Secondary:   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   [ Time Frame: Week 24 ]

7.  Secondary:   Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24   [ Time Frame: Week 24 ]

8.  Secondary:   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   [ Time Frame: Week 24 ]

9.  Secondary:   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   [ Time Frame: Week 24 ]

10.  Secondary:   Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]


  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: NCT01517412     History of Changes
Other Study ID Numbers: EFC12261
2011-002416-85 ( EudraCT Number )
U1111-1118-0841 ( Other Identifier: UTN )
Study First Received: January 16, 2012
Results First Received: August 22, 2016
Last Updated: August 22, 2016
Health Authority: United States: Food and Drug Administration