Merck's combo type 2 diabetes drug gets FDA thumbs up

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The FDA has approved Merck's Janumet XR (sitagliptin and metformin hydrochloride [HCl] extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

Janumet XR provides a once-daily treatment option for healthcare providers and patients who need help to control their blood sugar, according to Whitehouse Station, N.J.-based Merck. Janumet XR 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.

Merck added that Janumet XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Also, Janumet XR 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 XR. The FDA approved Janumet XR based upon a clinical bioequivalence study that demonstrated that administration of Janumet XR was equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and metformin HCl extended-release, Merck said.

The labeling for Janumet XR contains a boxed warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. Janumet XR is contraindicated in patients with renal impairment (e.g., serum creatinine levels >1.5 mg/dL for men, >1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse, acute MI and septicemia; hypersensitivity to metformin HCl; acute or chronic metabolic acidosis, including diabetic ketoacidosis (diabetic ketoacidosis should be treated with insulin); history of a serious hypersensitivity reaction to Janumet XR or sitagliptin, such as anaphylaxis or angioedema.