CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- According to findings presented today at the 67th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois, the investigational treatment liraglutide, a once- daily dose of human GLP-1 analog under development by Novo Nordisk for the treatment of type 2 diabetes significantly improved glycemic control (A1c) by reducing both fasting and post-meal glucose levels in people with type 2 diabetes. The Phase 2 study included 226 Japanese patients with type 2 diabetes treated over a period of 14 weeks. Results showed that liraglutide was effective and well tolerated within a wide dose range, allowing nearly 75 percent of patients receiving the highest dose to achieve glycemic control (A1c<7.0%) without hypoglycemia.(1)
"One challenge with insulin and many oral antidiabetic agents, which boost insulin secretion or heighten insulin sensitivity, is that they can lower blood glucose levels, resulting in hypoglycemia, which can sometimes be dangerous," said Professor Yutaka Seino, Director of Kansai-Denryoku Hospital and professor, Department of Metabolism & Clinical Nutrition, Graduate School of Medicine, Kyoto University, and lead investigator on the trial. "A well- tolerated agent with once-daily administration that can allow a majority of patients to achieve good glycemic control with a low risk of hypoglycemia and no weight gain is very promising and will be a considerable advance in diabetes treatment."
Liraglutide acts to lower blood glucose when levels are elevated, and previous studies have shown it is associated with a low risk of hypoglycemia.(2)(3)
About the Study (Abstract #0520-P)
In the study, 226 Japanese type 2 diabetes patients treated with diet or a single oral anti-diabetic drug, discontinued any diabetes drug for an eight- week period. Patients were then randomized to receive one of four once-daily doses of liraglutide (0.1, 0.3, 0.6, and 0.9 mg) or placebo. Baseline A1c levels ranged between 8.1 to 8.5%. The randomized, 14-week study showed statistically significant dose-dependent reductions in A1c levels (ranging from 0.79 to 1.85 percentage points - placebo adjusted, p<0.0001) after once- daily dosing of liraglutide monotherapy in these patients. Further, A1c levels below 7 percent were achieved by 22, 43, 62 and 75 percent of patients receiving liraglutide 0.1, 0.3, 0.6 and 0.9 mg/day compared with 9 percent of those receiving placebo. Additionally, in these normal-weight subjects (average BMI 23.9) no relevant changes in body weight or major or minor hypoglycemic events occurred in any study group.(1)
The main gastrointestinal adverse events in the high dose group versus placebo were: constipation (7% versus 9%), diarrhea (9% versus 4%), gastritis (7% vs. 0%) and nausea (7% versus 2%). No subject had a treatment-related increase in liraglutide antibodies.
Currently in phase 3 clinical trials, liraglutide is a human analog of the naturally occurring hormone, Glucagon-Like Peptide-1 (GLP-1), which is rapidly broken down in the body and thus not practical as a therapy for type 2 diabetes. GLP-1 is released from the gastrointestinal tract upon ingestion of food. When glucose levels become too high, GLP-1 triggers the release of insulin from the pancreas and decreases the secretion of glucagon, a hormone that promotes glucose synthesis in the liver. GLP-1 releases insulin in a glucose-dependent manner, meaning that it only triggers insulin secretion if blood glucose is too high. This characteristic is thought to result in a low risk of hypoglycemia, which has been confirmed in a number of studies in which GLP-1 was infused intravenously or subcutaneously.
Novo Nordisk is a healthcare company and a world lead er 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 more than 23,600 employees in 79 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 http://novonordisk.com.
1. Seino Y, Kaku K, Nishijima K, et al. "Once Daily Dosing of the long acting GLP-1 analogue Liraglutide Significantly Improves Glycaemic Control by Reducing both Fasting and Post-Prandial Glucose Levels In Japanese Subjects With Type 2 Diabetes." Poster presented (abstract # 0520-P) at the 67th Scientific Sessions of the American Diabetes Association, Chicago, IL, June 23-26 2007.
2. Vilsboell T, Brock B, Perrild H, et al. 14 weeks of liraglutide therapy in subjects with T2DM significantly improves 1st phase insulin secretion and maximal beta-cell secretory capacity. Late-breaking oral presentation (abstract 750195) at: 66th annual meeting of the American Diabetes Association, Washington, DC, June 9-13, 2006.
3. Vilsboell T, Zdravkovic M, Le-Thi T, et al. Liraglutide significantly improves glycemic control, and lowers body weight without risk of either major or minor hypoglycemic episodes in subjects with type 2 diabetes. Oral presentation (abstract # 115-OR) at: 66th annual meeting of the American Diabetes Association, Washington, DC, June 9-13, 2006. p>
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