Providing Glucose Control and Weight Loss Without Hypoglycaemia
BAGSVAERD, Denmark, Nov. 25, 2005 (PRIMEZONE) -- Novo Nordisk today announced clinical results from its phase 2b study of the safety and efficacy of liraglutide, the once-daily, fully-human GLP-1 analogue. The study, which was a double-blind, placebo-controlled, randomised, monotherapy study over 14 weeks, included 165 patients with type 2 diabetes that were previously treated with diet or oral antidiabetic agents.
An improvement of haemoglobinA1c (HbA1c) of between 1.5 and 2 percentage points was achieved by treatment with liraglutide compared to placebo. At the highest dose more than 45% of patients achieved a target of HbA1c equal to or below 7% compared to less than 8% treated with placebo. An HbA1c level below 7% is recommended by the American Diabetes Association. The average HbA1c level at the beginning of the study was just below 8.5%.
At the highest liraglutide dose, the improvement in fasting plasma glucose achieved was above 3 mM (greater than 54 mg/dl). In addition, these patients reduced their bodyweight by approximately 3 kg from a baseline of around 90 kg.
Liraglutide was well tolerated and nausea was reported at a level of 5-10%. Gastrointestinal side effects occurred most frequently in the beginning of the study, whereafter the frequency decreased substantially. There were no cases of major or minor hypoglycaemia in spite of the significant improvement in glycaemic control.
Mads Krogsgaard Thomsen, chief science officer and executive vice president of Novo Nordisk, said: "The impressive clinical data for liraglutide holds great promise for improving the treatment of type 2 diabetes; simultaneous glucose control and weight loss in the absence of hypoglycaemic events."
Novo Nordisk expects to communicate full results from the phase 2b study at a scientific meeting in 2006. As previously communicated, phase 3 studies with liraglutide including approximately 3,800 patients are expected to start in February 2006.
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis 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 21,600 full-time employees in 78 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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Stock Exchange Announcement no 28 / 2005
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