FDA approves new diabetes treatment
October 17, 2006The U.S. Food and Drug Administration has approved the use of Januvia tablets as the first in a new class of diabetes drugs.
The new drugs, known as DDP-4 inhibitors, enhance the body's ability to lower elevated blood sugar.
The FDA said it approved Januvia (sitagliptin phosphate) for use by patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications -- metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist -- when either of those drugs doesn't provide adequate blood sugar control.
Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all cases of diabetes. In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin.
Januvia was examined in 2,719 patients with type 2 diabetes during in studies lasting to more than a year. The studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.
The most common side effects were upper respiratory tract infection, sore throat, and diarrhea.
Januvia is manufactured by Merck and Co. Inc.
Copyright 2006 by United Press International
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