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: October 31, 2016

Last verified: October 2016

History of Changes

Results First Received: August 22, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, 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.
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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

6068

Age
[Units: Years]
Mean (Standard Deviation)

60.6 (9.6)

59.9 (9.7)

60.3 (9.7)

Gender
[Units: Participants]
Count of Participants

Female

938 30.9%

923 30.4%

1861 30.7%

Male

2096 69.1%

2111 69.6%

4207 69.3%

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

Not qualifying ACS event

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) ]

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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) ]

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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) ]

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Results Point of Contact:

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

Publications of Results:

Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

Other Publications:

Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Køber LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.

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

Wohlfart P, Linz W, Hübschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.

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:	October 31, 2016

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