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The FDA has approved Merck's sitagliptin phosphate (Januvia), the first diabetes treatment in a new class of drugs known as dipeptidyl peptidase IV (DPP-IV) inhibitors, which enhance the body's ability to lower high blood glucose.

 

The drug is indicated for use in addition to diet and exercise to improve blood glucose levels in patients with type 2 diabetes. Sitagliptin phosphate is approved for use alone or in combination with metformin or a peroxisome proliferator-activated receptor (PPAR) gamma agonist when either of these drugs alone (along with diet and exercise) don't provide adequate blood glucose control.

 

Sitagliptin prolongs the activity of proteins that increase the release of insulin after blood glucose rises, such as after a meal, by blocking the enzyme (DPP-IV) that breaks down these proteins.

 

In clinical trials of over 2,700 patients with type 2 diabetes, sitagliptin was shown to improve blood glucose control when used alone or in patients not satisfactorily managed with metformin or PPAR gamma agonists.

 

The most common adverse effects reported in the clinical trials were upper respiratory tract infection, sore throat, headache, and diarrhea.

 

Source

 

US Food and Drug Administration. Patient information sheet: Sitagliptin Phosphate. Available at: http://www.fda.gov/cder/drug/InfoSheets/patient/sitagliptin_phosphatePIS.htm. Accessed February 9, 2007.