Phase 3 data highlight sustained efficacy and benefits of early treatment
with liraglutide versus glimepiride
SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Data presented today at the 68th Scientific Sessions of the American Diabetes Association (ADA) demonstrated that once-daily liraglutide when taken alone produced statistically significant improvement in blood sugar (glucose) control in patients with type 2 diabetes, as compared to glimepiride, a widely used oral anti-diabetic drug (OAD).
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In addition, liraglutide demonstrated the following benefits compared
-- Statistically significant reduction in body weight
-- Statistically significant reduction in risk of hypoglycemia
-- Statistically significant reduction in systolic blood pressure
In this 12-month study, 62% of patients treated with liraglutide who had not been previously treated with diabetes medications achieved an average reduction in blood sugar that brought them below the ADA target for HbA1c of 7%.
"This study showed that when used as initial drug treatment for type 2 diabetes, once-daily liraglutide not only statistically significantly reduced blood glucose, weight, and systolic blood pressure, but sustained blood glucose reductions for the duration of the study in patients who had never taken diabetes medications before," said study investigator Robert E. Ratner, MD, Vice President for Scientific Affairs at the MedStar Research Institute in Washington, DC. "The sustained reduction in blood glucose suggests that liraglutide may be beneficial when used earlier in the course of diabetes."
About the Study
The data presented today are from the LEAD(TM) 3 study, one of the five studies which make up the Phase 3 program for liraglutide.
The double-blinded, double-dummy, randomized, parallel group, actively-controlled, multicenter, multinational 52-week trial compared the efficacy and safety of two doses of liraglutide (1.2 and 1.8 mg once daily) to glimepiride (8 mg once daily) in patients with type 2 diabetes treated with diet/exercise or not more than half the maximum dose of one OAD for greater than or equal to two months. Patients treated with diet and exercise had HbA1c between 7.0% and 11.0%. Patients previously treated with oral monotherapy had an HbA1c between 7.0% and 10.0%.
The data showed that at both doses tested, liraglutide provided substantial improvement in glucose control from baseline and statistically significantly better glucose control than glimepiride. Patients previously treated with diet and exercise had greater decreases in HbA1c, as compared to subjects switched from an OAD to liraglutide.
In addition, there was significant weight loss, as compared to weight
gain with glimepiride, and significantly greater reduction in systolic
blood pressure with both liraglutide groups compared to glimepiride.
Results of a 52-week trial of liraglutide monotherapy in patients with inadequate glucose control from previous diet and exercise or treatment with one OAD:
Liraglutide Liraglutide Glimepiride
1.8 mg 1.2 mg
N 246 251 248
HbA1c (%) (Mean)
Baseline 8.2 8.2 8.2
Change from baseline -1.14 -0.84 -0.51
treated patients -1.60 -1.19 -0.88
patients -0.71 -0.47 -0.17
achieving HbA1C <7%
All patients 50.9 42.8 27.8
patients 62.0 58.3 30.8
Body Weight (kg) (Mean)
Baseline 92.6 92.1 93.3
Change from baseline -2.45 -2.05 1.12
Safety and Tolerability of Liraglutide
There were no major hypoglycemic episodes reported during the study. The rate of minor hypoglycemia was statistically significantly lower in both liraglutide dose groups compared with the glimepiride-treated group. The most common adverse events were nausea, diarrhea, and vomiting, and most were short-term and mild or moderate in severity.
Liraglutide is a once-daily analog of the naturally occurring hormone human Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration (FDA) in the US as well as a marketing authorization application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide for the treatment of patients with type 2 diabetes.
About LEAD(TM) (Liraglutide Effect and Action in Diabetes)
The LEAD(TM) Program consists of five (four 26-week and one 52-week) randomized, controlled, double-blinded studies, involving more than 4000 patients with type 2 diabetes in 40 countries.
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 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 26,300 employees in 80 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.
|SOURCE Novo Nordisk|
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