Sanofi announced the full results of the first event-driven cardiovascular (CV) outcomes study on the safety of lixisenatide in patients with type 2 diabetes and high CV risk at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston, MA.
The Phase IIIb randomized double-blind, parallel group Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study evaluated 6,068 patients with type 2 diabetes who had recently experienced acute coronary syndrome events. Patients were randomly assigned to lixisenatide or placebo, with a follow-up period of more than two years. The composite primary endpoint was CV death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina.
Lixisenatide demonstrated non-inferiority to placebo for the composite primary endpoints but did not demonstrate superiority to placebo on these endpoints. There was no increased risk of heart failure, pancreatitis, pancreatic cancer, or severe symptomatic hypoglycemia observed.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes. Sanofi plans to include this data in its New Drug Application that is anticipated to be resubmitted to the Food and Drug Administration (FDA) later this year.
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