New Diabetes Drug Works Well in Trial

Could be approved for U.S. market by next year, researcher says

By Ed Edelson
HealthDay Reporter

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THURSDAY, Sept. 25 (HealthDay News) -- One of a new class of diabetes drugs has done well in a trial conducted to help bring it to market, researchers report.

The drug, liraglutide, is a laboratory-made version of glucagon-like peptide-1 (GLP-1), a hormone produced by the body. Several members of the GLP-1 family are in clinical trials, and one already has been approved by the U.S. Food and Drug Administration.

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In a phase 3 trial, usually the last kind done before marketing approval is sought, liraglutide had greater benefits against type 2 diabetes, the kind that generally develops in the adult years, than a now-standard medication, glimepiride, said a report in the Sept. 25 online issue of The Lancet.

Results of this trial and others have been given to the FDA, which will review them and decide whether to approve the drug for use in the United States, said trial leader Dr. Alan Garber, a professor of medicine, biochemistry and cell and molecular biology at Baylor College of Medicine, in Houston.

"It should be out sometime in the first half of next year," Garber said.

Like the other GLP-1 versions, liraglutide has all the advantages of the natural molecule, with longer-lasting activity, said Dr. Sten Madsbad, a professor of endocrinology at the University of Copenhagen in Denmark, who wrote an accompanying editorial.

"First it stimulates insulin production," Madsbad said. "Then it also promotes glucagon release from the pancreas. It also changes appetite, and therefore you eat less."

Glucagon is a hormone that helps manages blood levels of sugar.

The trial was sponsored by the pharmaceutical company Novo Nordisk, which hopes to market the drug. If approved, liraglutide would be the second GLP-1 diabetes medicine on the U.S. market. The first is exenatide (Byetta), which was approved by the FDA in 2005. It is marketed by Amylin Pharmaceuticals and Eli Lilly. It is taken by injection twice a day, while liraglutide requires only one daily injection.

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