Ridgefield, Conn., and Indianapolis, May 31, 2016 – The U.S. Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults. Jentadueto XR, which is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is the seventh new treatment from the Boehringer Ingelheim-Lilly Diabetes alliance to be approved by the FDA in the last five years.
Jentadueto XR combines 2.5 mg or 5 mg of linagliptin with 1000 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.
“Adults with type 2 diabetes are often required to take more than one medication to manage their condition, including some that have to be taken multiple times a day,” said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. “Jentadueto XR, the first extended-release therapy to emerge from our alliance with Lilly, offers adults with type 2 diabetes the convenience of a combination pill taken once a day to help lower blood sugar levels.”
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. Jentadueto XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, and has not been studied in people with a history of pancreatitis.
The Jentadueto XR 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 XR.
The safety and efficacy of Jentadueto XR have been established based on adequate and well-controlled studies of linagliptin and metformin co-administered in patients with T2D inadequately controlled on diet and exercise and in combination with sulfonylurea.