Enrolment of Victoza® (liraglutide) cardiovascular outcomes trial completed on schedule

Today, Novo Nordisk announced that recruitment for the LEADER® (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial assessing cardiovascular (CV) outcomes of the once-daily GLP-1 analogue, Victoza®, completed in April 2012, resulted in a high-risk population with patient numbers exceeding the original target. The baseline patient characteristics were presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

LEADER® is a major, worldwide phase 3b study focusing on patient safety with Victoza® as a treatment for type 2 diabetes mellitus. The long-term, double blind trial has been designed to assess the CV outcomes of Victoza® compared to placebo, both in addition to current standard of care for type 2 diabetes[1]. It is the largest and longest clinical trial in Novo Nordisk’s history with data from more than 17,000 patient years of exposure collected to date. It is a key part of the company’s ongoing global commitment to patient safety.

“Diabetes affects more than 370 million people worldwide[2],” says Dr Steven P. Marso, lead investigator of the LEADER® trial and Professor of Medicine, Mid America Heart Institute, Saint Luke’s Health System, Kansas City, Missouri. “It is linked with a nearly two-fold excess risk for a broad range of adverse cardiovascular outcomes[3] and there is a significant need for effective and safe blood sugar lowering treatments. Victoza® has a strong body of clinical evidence demonstrating its efficacy, both pre- and post-approval.”

Enrolment into the LEADER® trial began in September 2010 and concluded in April 2012. An additional 586 patients were recruited beyond the initial target. The trial includes 9,340 adults with type 2 diabetes from 410 sites across 32 countries. Of these patients 7,592 (81.3%) already had cardiovascular diseases and 1,748 (18.7%) were at high risk of developing it1. At the end of five years, results to be presented in 2016 are expected to describe the CV safety of Victoza® relative to current standard of care.

An independent Data Monitoring Committee (DMC) is closely observing and assessing the progress of the trial to ensure that it meets the highest standards of ethics and patient safety. The protocol for the LEADER® trial has been designed in close collaboration with an international expert Steering Committee as well as US and EU regulatory authorities, and with assistance from the Population Health Research Institute (PHRI) at McMaster University, Canada.

About Victoza®

Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia†. In addition, Victoza® reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake.

Victoza® was launched in the EU in 2009 and is commercially available in more than 60 countries globally. Currently, there are more than 750,000 Victoza® patients worldwide. In the US, Victoza® was approved on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

† Hypoglycaemia has primarily been observed when Victoza® is combined with a sulphonylurea

About LEADER®

LEADER® (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) is a long-term, multicentre, international, randomised, double-blind, placebo-controlled, phase 3b trial having included 9,340 patients to be followed over a five-year period. People with type 2 diabetes were recruited from 32 countries around the world: Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, and the United States of America. The trial will compare Victoza® added to standard of care with standard of care alone in people with type 2 diabetes.

References

1. Marso S, et al. Design of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) Trial. Oral presentation 74 at 49th European Association for the Study of Diabetes Annual Meeting, 25 September 2013.
2. International Diabetes Federation. Diabetes Atlas Fifth Edition Update 2012. Available at URL: http://www.idf.org/diabetesatlas/5e/Update2012 Last accessed: February 2013
3. Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, et al. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet 2010;375:2215-22.