FDA Approves Once-Daily Jentadueto XR (Linagliptin/ Metformin) for Adults With Type-2 Diabetes

Extended-release formulation improves glycemic control

The FDA has given the green light to Jentadueto XR (linagliptin and metformin hydrochloride extended-release tablets, Boehringer Ingelheim/Lilly) for the treatment of type-2 diabetes (T2D) in adults. The product combines 2.5 mg or 5.0 mg of linagliptin with 1,000 mg of metformin.

Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.

Jentadueto XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both linagliptin and metformin is appropriate. The product should not be used in patients with type-1 diabetes or for the treatment of diabetic ketoacidosis, and it has not been studied in people with a history of pancreatitis.

The Jentadueto XR label includes a boxed warning regarding the risk of lactic acidosis, a serious metabolic complication that can occur because of metformin accumulation during treatment with Jentadueto XR.

The safety and efficacy of Jentadueto XR have been established based on studies of linagliptin and metformin coadministered in patients with T2D who were inadequately controlled on diet and exercise and in combination with sulfonylurea.

Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, and nearly 28% of Americans with diabetes—totaling eight million people—are undiagnosed. In the U.S., approximately 12% of people 20 years of age and older have diabetes. T2D is the most common type, accounting for an estimated 90% to 95% of all cases of diagnosed adult diabetes in the U.S.

Source: Eli Lilly; May 31, 2016.