FDA approves new diabetes treatment
October 17th, 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
Jul 03, 2009 |
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