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Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) (ELIXA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01147250
First received: June 17, 2010
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: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo

  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 829 centers in 49 countries. A total of 7719 participants were screened between June 24, 2010 and July 24, 2013. 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7627 participants underwent 1 week placebo run-in period. 1559 were run-in failures due to exclusion criteria met. 6068 participants were randomized 1:1 to lixisenatide and placebo arms in double-blind treatment period. Duration of study was event driven until approximately 844 positively adjudicated primary cardiovascular (CV) outcome events.

Reporting Groups
  Description
Placebo Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
Lixisenatide Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).

Participant Flow:   Overall Study
    Placebo   Lixisenatide
STARTED   3034   3034 
Treated   3032   3031 
COMPLETED   2924   2929 
NOT COMPLETED   110   105 
Lost to Follow-up                14                11 
Withdrawal by Subject                83                88 
Site termination by sponsor                13                5 
Other than specified                0                1 



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
Lixisenatide Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Total Total of all reporting groups

Baseline Measures
   Placebo   Lixisenatide   Total 
Overall Participants Analyzed 
[Units: Participants]
 3034   3034   6068 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (9.6)   59.9  (9.7)   60.3  (9.7) 
Gender 
[Units: Participants]
     
Female   938   923   1861 
Male   2096   2111   4207 
Race 
[Units: Participants]
     
Caucasian/White   2318   2258   4576 
Black   103   118   221 
Asian/Oriental   367   404   771 
Other   246   254   500 
Ethnicity 
[Units: Participants]
     
Hispanic   903   865   1768 
Not Hispanic   2131   2169   4300 
Qualifying Acute Coronary Syndrome (ACS) event 
[Units: Participants]
     
ST-segment elevation myocardial infarction (MI)   1317   1349   2666 
Non ST-segment elevation MI   1183   1165   2348 
Unstable angina   528   514   1042 
Unclassified   4   5   9 
Not qualifying ACS event   2   1   3 
Body Mass Index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.2  (5.79)   30.12  (5.6)   30.16  (5.69) 
[1] N=3032, 3033
Body Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 85.06  (19.64)   84.64  (19.21)   84.85  (19.43) 
[1] N=3032, 3033
Glycosylated Hemoglobin (HbA1c) [1] 
[Units: Percentage of HbA1c]
Mean (Standard Deviation)
 7.64  (1.28)   7.72  (1.32)   7.68  (1.30) 
[1] N=3033, 3034
Duration of Diabetes [1] 
[Units: Years]
Mean (Standard Deviation)
 9.38  (8.32)   9.2  (8.19)   9.29  (8.25) 
[1] N=3034, 3031


  Outcome Measures
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1.  Primary:   Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina   [ Time Frame: From randomization up to the end of study (median follow-up of 25 months) ]

2.  Secondary:   Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure   [ Time Frame: From randomization up to the end of study (median follow-up of 25 months) ]

3.  Secondary:   Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure   [ Time Frame: From randomization up to the end of study (median follow-up of 25 months) ]

4.  Secondary:   Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108   [ Time Frame: Baseline to Week 108 (LOCF) ]


  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: Trail Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01147250     History of Changes
Other Study ID Numbers: EFC11319
2009-012852-26 ( EudraCT Number )
U1111-1116-5558 ( Other Identifier: UTN )
Study First Received: June 17, 2010
Results First Received: August 22, 2016
Last Updated: August 22, 2016
Health Authority: United States: Food and Drug Administration