Novo Nordisk study shows liraglutide aids glucose control, weight loss in diabetics

By Ted A. Knutson

Washington, Nov. 28 - Novo Nordisk A/S's phase 2b safety and efficacy study of liraglutide, the once-daily, fully-human GLP-1 analogue, showed the drug helps with glucose control and weight loss in diabetics, according to a company news release Monday.

The research, which was a double-blind, placebo-controlled, random, 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% 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 with less than 8% treated with placebos. 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 (> 54 mg/dl). In addition, these patients reduced their bodyweight by about 3 kg from a baseline of around 90 kg.

Liraglutide was well tolerated and nausea was reported at a level of 5% to 10%. Gastrointestinal side effects occurred most frequently in the beginning of the study, then the frequency decreased substantially. There were no cases of major or minor hypoglycaemia in spite of the significant improvement in glycaemic control, the company 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," said Mads Krogsgaard Thomsen, chief science officer and executive vice president of Novo Nordisk.

Novo Nordisk expects to release full results from the phase 2b study at a scientific meeting in 2006. As previously communicated, phase 3 studies with liraglutide including about 3,800 patients are expected to start in February.

Bagsvaerd, Demark-based Novo Nordisk makes diabetes treatment medications.

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