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

What Was Tested

In this phase 3 trial, researchers set out to test Lixisenatide.

To assess the safety and tolerability of lixisenatide.

It had two arms (groups): Placebo (placebo comparator) and Lixisenatide (experimental).

Placebo matched to lixisenatide once daily (QD) up to end of treatment.

The registry classes the interventions as drug.

More on the Plan

The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.

Who Took Part

The registry lists 6068 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening; participants who had undergone coronary artery bypass graft (cabg) surgery following the qualifying acs event; participants who had undergone percutaneous coronary intervention (pci) within 15 days prior to screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Lixisenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Lixisenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2010-06 with completion listed for 2015-02.

It ran at 829 sites in United States (200), Russia (55), Argentina (46), United Kingdom (31), Chile (29) and Mexico (28).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lixisenatide in 6068 people.

With 6068 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Lixisenatide compound page, all human trials.