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

NCT01147250 · Completed

Last updated 2026-05-28

This clinical trial tested the drug lixisenatide in adults with type 2 diabetes who had recently experienced a heart-related event to see if it could help prevent future heart problems.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 6,068 people

Who can join Ages 30+ · all sexes

Timeline Started 2010-06 · est. completion 2015-02

Where 829 sites · Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Guatemala, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01147250 ↗

Description as written by the study sponsor.

Primary Objective: \- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. * urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

Treatments tested

Lixisenatide (AVE0010) also known as Lyxumia Drug

Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.
Placebo Drug

Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.

Main thing measured	Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
Sponsor	Sanofi
Conditions studied	Acute Coronary Syndrome
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01147250 ↗