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The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide
Date:6/8/2009

NEW ORLEANS, June 8 /PRNewswire/ -- Today, The Lancet published online the results of the Novo Nordisk (NVO) LEAD(TM) 6 study, a direct comparison between two products in a new class of diabetes treatments, the GLP-1 receptor agonists. Results show that patients treated with liraglutide had a statistically greater drop in A1C than those who received exenatide.

The study compared liraglutide, a human GLP-1 analog, which is under investigation as a treatment for type 2 diabetes, to exenatide, the currently marketed GLP-1 receptor agonist.

"Because of the differences in how the body absorbs and eliminates these two compounds, we were very interested to see if there were clinically meaningful differences in the effect in people with diabetes," said Dr. John Buse, chief of endocrinology and director of the Diabetes Care Center at the University of North Carolina School of Medicine, and one of the principal investigators in the study. "The clinical benefits that liraglutide provides -- from greater glucose lowering to weight loss to better tolerability and improvements in beta-cell function -- represent a clinically meaningful treatment advance for patients with type 2 diabetes."

LEAD(TM) 6 was a randomized, open-label study comparing the efficacy and safety of liraglutide 1.8 milligrams, once a day, to exenatide 10 micrograms, twice a day.

Treatment with liraglutide led to a statistically significantly greater drop in A1C of 1.12% compared to 0.79% in the exenatide group, and liraglutide was also significantly better than exenatide at lowering fasting plasma glucose (-1.61 mmol/L vs -0.60 mmol/L) in this typical type 2 diabetes population. The study comprised 464 patients who were not reaching recommended blood sugar targets on either the maximally tolerated doses of metformin, sulphonylurea, or both, which are standard oral antidiabetic medications currently available.

Both treatments led to a weight reduction of on average 3 kg during the 26-week study. Nausea was the most commonly reported adverse event with both treatments but the study results showed that there was less persistent nausea and fewer minor hypoglycemic events with liraglutide compared to exenatide.

The most common adverse events reported in both groups were diarrhea, indigestion, nausea, common cold and headache.

Novo Nordisk announced results from the LEAD(TM) 6 study in a stock exchange announcement dated June 6, 2008 and a press release dated October 17, 2008.

About liraglutide

Once-daily liraglutide is the first human glucagon-like peptide-1 (GLP-1) analog developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin only when blood sugar levels are high. Weight loss with liraglutide is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Liraglutide is naturally broken down in the body and does not require renal excretion.

On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration (FDA) in the U.S., as well as a marketing authorization application to the European Medicines Agency (EMEA), for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.

On April 23, 2009, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the EMEA adopted a positive opinion, recommending marketing authorization of liraglutide for treatment of type 2 diabetes in Europe.

In the U.S., a regulatory decision is pending.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 27,900 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.


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