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Data from a phase 3 study of the Novo Nordisk drug liraglutide shows that when it is used in combination with glimepiride, it is more effective at reducing A1c's than glimepiride by itself or glimepiride in combination with the drug rosiglitazone.
A phase 3 study is the last step before a drug receives approval from government agencies to go to market. Novo Nordisk currently has applications before the U.S. Food and Drug Administration, the European Medicines Agency, and the Japanese government for approval to market liraglutide as a treatment for type 2 diabetes.
Researchers conducted a 26-week double-blind trial with more than 2,000 type 2 patients. Patients were randomly selected to receive one of the following treatments:
By the end of the study, patients on the liraglutide-glimepiride combination experienced a 1.08 percent (1.2 mg dose group) and 1.13 percent (1.8 mg dose group) reduction in their baseline A1c's, compared to a 0.44 percent reduction in the glimepiride-rosiglitazone group.
The mean weight loss benefit for patients on the liraglutide-glimepiride combination was more than 2 kilograms (about 4.5 pounds) greater than that for patients on glimepiride-rosiglitazone.
Liraglutide is a glucagon-like peptide-1 analog that stimulates the release of insulin when blood sugar levels are elevated and inhibits the release of glucagon from the liver. Taken once daily by injection, the drug often leads to weight loss in patients because it slows gastric emptying, thus delaying the onset of hunger pangs.
A drug like liraglutide is often the second drug that doctors prescribe for type 2s as their disease progresses. Typically, newly diagnosed types 2s start with metformin, which may later be joined by a sulfonylurea like glimepiride.
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