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Novo Nordisk’s New GLP-1 Drug Liraglutide Completes Phase 2b Study Successfully

Drops A1c by 1.5 to 2 points and drops body weight by 6.6 pounds in 14 weeks, without hypoglycemia.

Novo Nordisk announced, last Friday, 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, randomized, 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 hypoglycemia in spite of the significant improvement in glycemic 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 hypoglycemic 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.
NovoNordisk, USA

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DID YOU KNOW:
Hypoglycemia before the age of 5, effects long-term memory more than in older children: Severe hypoglycemia is a common side-effect of strict glycemic control and is a significant and relatively common complication of insulin treatment in children with type 1 diabetes. It has recently been hypothesized from study results, that severe hypoglycemia before the age of 5 years has a worse effect on spatial memory than severe hypoglycemia at an older age because of the vulnerability of developmental skills and the underlying neural systems. Diabetes Care,28 (2372-2377): Hershey T, Perantie D, Warren S, Zimmerman E, Sadler M, White N Frequency and timing of severe hypoglycemia affects spatial memory in children with type 1 diabetes