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Novo Nordisk New Data From a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes
Date:9/8/2008

ROME, Sept. 8 /PRNewswire-FirstCall/ -- Novo Nordisk (NYSE: NVO), a global healthcare company, presented data from a phase 3 clinical study (LEAD(TM) 4) today at the 44th annual meeting of the European Association for the Study of Diabetes that demonstrated adding the investigational new drug liraglutide, a human GLP-1 analog, to metformin and rosiglitazone in the treatment of type 2 diabetes, leads to improved blood glucose lowering (HbA1c), weight loss, blood pressure reduction and improvements in beta-cell functioning.

Participants in the study were randomized to receive liraglutide (1.8 mg or 1.2 mg dose) or placebo for 26 weeks in addition to metformin and rosiglitazone. Treatment with liraglutide in addition to metformin and rosiglitazone resulted in a mean reduction of 1.5% from baseline HbA1c. Fasting blood glucose levels decreased by 2.4 mmol/L within two weeks on 1.8 mg of liraglutide. More than half of the patients who received liraglutide reached the American Diabetes Association HbA1c target of <7.0% compared to 28% of those who received placebo. Likewise, more than 35% of the patients in the liraglutide groups reached HbA1c < or = 6.5% compared to 14% in the placebo group. In both cases, the difference between the groups receiving liraglutide and the group treated with metformin and rosiglitazone alone was statistically significant.

In addition to improved glucose lowering, liraglutide treatment also led to significant weight loss. Mean body weight decreased significantly for liraglutide compared to an increase in weight of 0.6 kg in the metformin and rosiglitazone only group. Weight is a common problem among individuals with type 2 diabetes and is one of the most challenging aspects in managing this condition.
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