FDA Approves Merck’s New Type 2 Diabetes Drug Janumet

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The FDA has approved Merck’s (MSD) new type 2 diabetes medication, JANUMET XR (sitagliptin and metformin hydrochloride (HCl) extended-release) The new treatment combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.  Janumet targets three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver.

Janumet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and extended-release metformin is appropriate. Patients also receiving an insulin secretagogue (e.g., sulfonylurea) or insulin may require a lower dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. 

Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.  Janumet has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using  Janumet .

Earlier this week the FDA approved another type 2 diabetes combination treatment Jentadueto (linagliptin/metformin hydrochloride), which combines linagliptin (the active ingredient in Tradjenta™ (linagliptin) tablets) and metformin.

 

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