Novo Nordisk has announced results from the LEADER trial, which investigated the cardiovascular safety of liraglutide (Victoza) during a period of up to five years in more than 9,000 adults with type-2 diabetes at high risk for major adverse cardiovascular events.
The LEADER trial was an international, randomized, double-blind, placebo-controlled study investigating the long-term effects of liraglutide (1.2 mg and 1.8 mg) compared with placebo, both in addition to standard of care, in patients with type-2 diabetes at high risk of cardiovascular events. The trial was initiated in September 2010 and followed 9,340 diabetes patients for three and a half to five years. The study’s primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
The trial met its primary endpoint, demonstrating noninferiority as well as superiority, with a statistically significant reduction in cardiovascular risk. The superior reduction of major adverse cardiovascular events demonstrated by liraglutide was derived from all three components of the endpoint. The safety profile of liraglutide in this study was generally consistent with that seen in previous liraglutide clinical trials.
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence that is 97% similar to that of endogenous human GLP-1.It was approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.
Detailed results of the new study are planned to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016.
Source: Novo Nordisk; March 4, 2016.