The LEADER trial is the latest in a recent wave of cardiovascular outcomes trials now required by FDA for diabetes and obesity therapies. Full results will be reported in June at the meeting of the American Diabetes Association.
Topline results show that liraglutide, marketed for patients with type 2 diabetes as Victoza, reduced the risk of major adverse cardiovascular events for these patients over a 5-year period.
Results of the LEADER trial were reported Friday by drugmaker Novo Nordisk, which also markets a different dose of liraglutide for patients with obesity under the brand name Saxenda.
Liraglutide is a glucagon-like peptide (GLP-1) receptor agonist; it is approved in 1.2 mg and 1.8 mg doses for the treatment of T2D. The larger 3 mg dose is approved for treatment of obesity.
Reuters reported that shares of Novo Nordisk jumped 7% on the news.
According a statement from Novo Nordisk, the trial in 9000 adults compared the addition of either liraglutide or placebo to standard of care, and met the primary endpoint of showing noninferiority as well as demonstrated superiority, with a statistically significant reduction in cardiovascular risk.
The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by liraglutide was derived from all 3 components of the endpoint.
Safety outcomes were consistent with previous clinical trials.
"People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That's why we are very excited about the results from LEADER, which showed that Victoza, in addition to helping people with type 2 diabetes control their blood sugar levels, also reduces their risk of major adverse cardiovascular events," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The FDA has required long-term cardiovascular outcomes trials since an incident involving the blockbuster T2D therapy, rosiglitazone. At its peak, the drug reached $3.2 billion in sales in 2006. But the drug was reported to be associated with heart attacks in an article in the New England Journal of Medicine, and the FDA bowed to pressure and restricted its use.
Although a study by Duke researchers later cleared the drug, the action had little practical effect. However, the incident forced a rethinking in trial design and safety requirements for diabetes and obesity therapies.
Novo Nordisk’s statement said full results will be presented at the 76th Scientific Sessions of the American Diabetes Association, to be held in New Orleans, Louisiana, in June 2016.