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Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01596504
First received: May 7, 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: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Liraglutide
Drug: Insulin Glargine
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 8 centers in Germany between 22 May 2012 to 25 July 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 236 participants were screened and 142 participants were randomized and treated.

Reporting Groups
  Description
Lixisenatide 20 μg Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
Liraglutide 1.2 mg Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
Liraglutide 1.8 mg Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.

Participant Flow:   Overall Study
    Lixisenatide 20 μg   Liraglutide 1.2 mg   Liraglutide 1.8 mg
STARTED   48   47   47 
COMPLETED   46   44   46 
NOT COMPLETED   2   3   1 
Participant's Private Reason                0                1                0 
Adverse Event                1                2                1 
Withdrawal by Subject                1                0                0 



  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 20 μg Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
Liraglutide 1.2 mg Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
Liraglutide 1.8 mg Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
Total Total of all reporting groups

Baseline Measures
   Lixisenatide 20 μg   Liraglutide 1.2 mg   Liraglutide 1.8 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   47   47   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (7.4)   61.4  (7.9)   62.6  (9.4)   61.9  (8.3) 
Gender 
[Units: Participants]
       
Female   15   8   14   37 
Male   33   39   33   105 
Race 
[Units: Participants]
       
Caucasian/White   48   46   47   141 
Other   0   1   0   1 
Metformin Use at Screening 
[Units: Participants]
       
Yes   43   41   41   125 
No   5   6   6   17 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 90.56  (13.09)   91.62  (13.92)   92.92  (15.33)   91.69  (14.07) 
Body Mass Index (BMI) 
[Units: (kg/m²)]
Mean (Standard Deviation)
 30.68  (4.34)   30.52  (4.01)   31.17  (4.34)   30.79  (4.22) 
HbA1c at Screening (Day -7) 
[Units: Percentage of haemoglobin]
Mean (Standard Deviation)
 7.22  (0.48)   7.19  (0.53)   7.33  (0.5)   7.25  (0.50) 


  Outcome Measures
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1.  Primary:   Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours   [ Time Frame: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56 ]

2.  Secondary:   Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours   [ Time Frame: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 ]

3.  Secondary:   Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56   [ Time Frame: Day 56 ]

4.  Secondary:   Change From Baseline to Day 56 in PPG Excursion   [ Time Frame: 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 ]

5.  Secondary:   Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)   [ Time Frame: 0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56 ]

6.  Secondary:   Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)   [ Time Frame: Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56 ]

7.  Secondary:   Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours   [ Time Frame: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 ]

8.  Secondary:   Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours   [ Time Frame: 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 ]

9.  Secondary:   Change From Baseline to Day 56 in HbA1c   [ Time Frame: Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56 ]

10.  Secondary:   Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose   [ Time Frame: Day -7 (Baseline), Day 56 ]

11.  Secondary:   Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)   [ Time Frame: 0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55 ]

12.  Secondary:   Change From Baseline to Day 55 in Gastric Emptying Coefficient   [ Time Frame: 0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55 ]

13.  Secondary:   Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate   [ Time Frame: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58 ]

14.  Secondary:   Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure   [ Time Frame: Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58 ]

15.  Secondary:   Change From Baseline to Day 57 in Body Weight   [ Time Frame: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57 ]

16.  Secondary:   Change From Baseline to Day 57 in Waist Circumference   [ Time Frame: 0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57 ]

17.  Secondary:   Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast   [ Time Frame: 0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56 ]


  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: NCT01596504     History of Changes
Other Study ID Numbers: PDY12625
2012-000027-40 ( EudraCT Number )
U1111-1124-1364 ( Other Identifier: UTN )
Study First Received: May 7, 2012
Results First Received: August 22, 2016
Last Updated: August 22, 2016
Health Authority: Germany: Ethics Commission