Bagsværd, Denmark, 4 March 2016 - Novo Nordisk today announced the top-line results from the LEADERtrial, which investigated the cardiovascular safety of Victoza® (liraglutide) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes at high risk of major adverse cardiovascular events. The trial compared the addition of either Victoza® or placebo to standard of care and met the primary endpoint of showing non-inferiority as well as demonstrating 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, non-fatal myocardial infarction or non-fatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by Victoza® was derived from all three components of the endpoint.
The safety profile of Victoza® in LEADER was generally consistent with previous liraglutide clinical studies.
"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. "LEADER is the largest and longest Novo Nordisk clinical trial to report to date, and we look forward to sharing the detailed results with the medical community and submitting the findings to the regulatory authorities."
The detailed results are planned to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016.
On 4 March 2016 at 2.00 pm CET, corresponding to 8.00 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.
LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term effects of Victoza® (1.2 and 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of cardiovascular events. The trial was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries that were followed for 3.5-5 years. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1.
Victoza® was launched in the EU in 2009 and is commercially available in more than 80 countries with more than 3 million patient years of use in people with type 2 diabetes globally. In Europe, Victoza® is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. Victoza® was approved by the U.S. Food and Drug Administration in 2010, as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
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Company announcement No 20 / 2016