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Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01476475
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
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: Insulin glargine /lixisenatide Fixed Ratio Combination
Drug: Insulin glargine
Drug: Metformin (Background drug)

  Participant Flow

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 70 centers in 13 countries. A total of 520 participants were screened between November 21, 2011 and June 08, 2012. Out of 520 participants, 197 were screen failure; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of the protocol defined range.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 323 participants were randomized in 1:1 ratio to insulin glargine/lixisenatide fixed ratio combination (FRC) and insulin glargine arms, stratified by screening HbA1c values (<8% or ≥8%) and screening body mass index (BMI) values (<30 kg/m^2, ≥30 kg/m^2).

Reporting Groups
  Description
Insulin Glargine/Lixisenatide Fixed Ratio Combination FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
Insulin Glargine Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.

Participant Flow:   Overall Study
    Insulin Glargine/Lixisenatide Fixed Ratio Combination   Insulin Glargine
STARTED   161   162 
COMPLETED   150   159 
NOT COMPLETED   11   3 
Adverse Event                6                0 
Poor compliance to protocol                1                1 
Other reasons                4                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Insulin Glargine/Lixisenatide Fixed Ratio Combination FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
Insulin Glargine Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
Total Total of all reporting groups

Baseline Measures
   Insulin Glargine/Lixisenatide Fixed Ratio Combination   Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 161   162   323 
Age 
[Units: Years]
Mean (Standard Deviation) 		 56.9  (9.5)   56.6  (9.4)   56.7  (9.4) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      81  50.3%      77  47.5%      158  48.9% 
Male      80  49.7%      85  52.5%      165  51.1% 
Race 
[Units: Participants]
 		     
Caucasian/White   158   160   318 
Black   2   1   3 
Asian/Oriental   1   1   2 
Ethnicity 
[Units: Participants]
 		     
Hispanic   35   30   65 
Non Hispanic   126   132   258 
Screening HbA1c 
[Units: Percentage of haemoglobin]
Mean (Standard Deviation) 		 8.12  (0.80)   8.08  (0.77)   8.10  (0.78) 
Baseline BMI 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 32.24  (4.75)   32.02  (4.35)   32.13  (4.55) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation) 		 6.29  (4.29)   7.10  (5.27)   6.69  (4.82) 
Daily Dose of Metformin 
[Units: Mg]
Mean (Standard Deviation) 		 2075.8  (440.7)   2093.7  (415.5)   2084.8  (427.7) 
Fasting Plasma Glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation) 		 9.76  (2.19)   9.46  (2.16)   9.61  (2.18) 


  Outcome Measures

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

2.  Secondary:   Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 2

3.  Secondary:   Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 4

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

6.  Secondary:   Average Daily Insulin Glargine Dose at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 6

7.  Secondary:   Change in FPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period   [ Time Frame: Baseline up to Week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Change in 30-minute and 1-hour PPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 10

11.  Secondary:   Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period   [ Time Frame: Baseline up to Week 24 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days) ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT01476475     History of Changes
Other Study ID Numbers: ACT12374
2011-002090-36 ( EudraCT Number )
U1111-1121-7111 ( Other Identifier: UTN )
First Submitted: November 4, 2011
First Posted: November 22, 2011
Results First Submitted: December 16, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017