Lixisenatide treatment in type 2 diabetes with acute coronary syndrome

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome

• IRAS ID

  38877

• Contact name

  Edward Jude

• Sponsor organisation

  sanofi-aventis

• Eudract number

  2009-012852-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The prevalence of type 2 diabetes has increased to epidemic proportions worldwide and people with diabetes have an increased risk of cardiovascular diseases and complications leading to a decreased life expectancy. Intensive blood glucose control in diabetes decreases the risk of complications related to vascular disease. Lixisenatide belongs to the class of Glucagon-like peptide 1 (GLP-1) receptor agonists and is being developed for the treatment of patients with type 2 diabetes. The main aim of this study is to investigate the effect of Lixisenatide on cardiovascular outcomes as compared to placebo using various outcome tests. This will be studied in patients with type 2 diabetes who have experienced an acute coronary syndrome (ACS), i.e. a specific form of angina or heart attack, between 5 days and 12 weeks before the screening visit. Eligible patients will be randomly assigned to Lixisenatide or placebo treatment groups and the study will comprise 3 periods: 1 - the screening and run in period where eligible patients will be identified and trained to self inject the placebo. 2 - the double blind treatment period where the patient will be randomly assigned to receive either Lixisenatide or placebo for approximately 14 to 41 months (median duration of 23.5 months). After randomization the dose of the study drug will be increased to the specified higher dose over a two week period if tolerable. The patient will then be asked to attend site at regular intervals for visits that will alternate with telephone contacts by the site personnel every 6-8 weeks. 3 - a follow-up safety phone call performed 3 days after treatment completion. It is hoped that this research study can show that this new experimental medication, Lixisenatide, may improve the cardiovascular outcomes for these patients.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/38

• Date of REC Opinion

  11 Jun 2010

• REC opinion

  Further Information Favourable Opinion