ADA: Investigational Diabetes Drug Liraglutide Sheds Fat 

In a 160-patient analysis of body composition at baseline and six months, there was a significantly greater reduction in fat mass with those randomized to liraglutide than to the sulfonylurea drug glimepiride (Amaryl), according to Johan Jendle, M.D., Ph.D., of Orebro University Hospital in Orebro, and colleagues.

Higher doses of liraglutide were associated with more than a one-percentage point reduction in total body fat over 26 weeks whereas glimepiride was associated with a gain of about 0.4 percentage points (P<0.05), they reported at the American Diabetes Association meeting here.

Whereas liraglutide reduced body fat by more than 2 kg, glimepiride increased fat mass by about 1 kg. However, neither drug changed body composition significantly compared with placebo, the researchers said.

People are excited about therapies associated with weight loss, commented John Buse, M.D., of the University of North Carolina at Chapel Hill, and ADA president for medicine and science, who was not involved in the study. He noted that most diabetes drugs are associated with gain, including the mainstays -- the sulfonylureas, insulin, and glitazone.

Liraglutide is an exception, along with exenatide, metformin, and a few others, he said. "The weight loss on average is moderate but everybody hopes to be in that top 25% that lose 20 or 30 pounds over a period of six months to a year."
Liraglutide is a human glucagon-like peptide 1 analogue (GLP-1) that acts to increase insulin secretion and suppress secretion of glucagon, which opposes the action of insulin. An NDA for the agent was filed last month with the FDA, said Novo Nordisk.

Dr. Jendle's group conducted a substudy in the LEAD-2 study. This double-blind international trial randomized 1,041 patients with type 2 diabetes to metformin plus liraglutide at a dose of 1.8, 1.2, or 0.6 mg; placebo; or glimepiride at a dose of 4 mg.

The substudy included 160 patients who underwent dual x-ray absorptiometry scans for body composition analysis at baseline and six months.  The reduction in glycolated hemoglobin (HbA1c) was similar at up to 1.3% with liraglutide and 1.2% with glimepiride.

Weight loss occurred over the course of 26 weeks of treatment in all groups except the glimepiride group. Placebo was associated with about a 1.5 kg loss compared with baseline. Weight loss was dose dependent with liraglutide from just under 2 kg to nearly 3 kg in the highest dose group. These changes were accounted for by changes in both fat and lean mass, but the majority of mass lost was fat with liraglutide whereas placebo was associated with more lean than fat mass loss. Glimepiride treatment increased both lean and fat mass to a nearly equal degree.

The two higher doses of liraglutide were associated with significant losses in visceral fat area as assessed by CT compared with baseline (P<0.05) and in subcutaneous fat area compared with glimepiride (P<0.01).

Liver steatosis was also improved in the highest dose liraglutide group (P<0.05) without a change in either the placebo or glimepiride group.

Diabetes Association meeting: Jendle J, et al "Liraglutide, a once-daily human GLP-1 analog, reduces fat percentage, visceral and subcutaneous adipose tissue and hepatic steatosis compared with glimepiride when added to metformin in subjects with type 2 diabetes" ADA meeting 2008; Abstract 106-OR.

Presented at the American Diabetes Association’s 68th Annual Scientific Sessions.

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