FDA clears Boehringer, Lilly's type 2 diabetes drug

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The FDA has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly's Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin and metformin.

Jentadueto provides a single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets. Jentadueto is now a prescription medication to be used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate, according to the companies. The drug can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes.

Jentadueto is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin. The Jentadueto label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.