FDA OKs Sale of Combo Drug JANUMET

The FDA has approved US sales of JANUMET® XR, a daily oral treatment for type 2 diabetes that combines sitagliptin and extended-release metformin. The drug is the fourth oral type 2 diabetes treatment introduced by Merck, which also sells JANUVIA, JANUMET, and JUVISYNC.

Sitagliptin is a DPP-4 (dipeptidyl peptidase-4) inhibitor that reduces the production of glucagon, a pancreatic hormone that increases blood glucose levels. Metformin, an established and widely used drug for treating type 2, works by decreasing the liver’s production of glucose.

Merck’s randomized, double-blind, placebo-controlled study of JAMUMET XR in 1,091 type 2 patients showed that over a 24-week period, the sitagliptin-metformin combination helped patients achieve a 2.1% reduction in A1C levels, down from a mean baseline of 8.8%.

JANUMET XR’s once-daily regimen makes it easier for type 2 patients to follow their therapy routine. Dosage of the drug may vary according to whether patients are taking other drugs, such as insulin or sulfonylureas. JANUMET XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.


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