Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes

Status Completed

Clinical Trial Summary

Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

- composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure

- composite endpoint of cardiovascular 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.

Clinical Trial Description

The estimated maximum study duration for the first randomized patient will be approximately 204 weeks (± 14 days), with a median follow-up over all patients of approximately 91 weeks, broken down as follows:

- placebo-run-in period: 7 days (+ 3 days)

- double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)

- post-treatment follow-up period: 3 days (± 1 day)

All patients will be followed from randomization until the end of study, which should occur when the last randomized patient has been followed for approximately 10 months. The actual end date of the study will be "event driven"and the study will end when there are approximately 844 positively-adjudicated primary cardiovascular outcome events. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01147250
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 3
Start date	June 2010
Completion date	February 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms