FDA Approves Extended Release Tablets for Adults with Type 2 Diabetes

The FDA has approved linagliptin and metformin hydrochloride extended-release (Jentadueto XR) tablets for adults with type 2 diabetes.

Jentadueto XR, which combines 2.5 mg or 5 mg of linagliptin and 1000 mg of metformin, can be used as an adjunct to diet and exercise to improve glycemic control.

In trials, Jentadueto XR demonstrated safety and efficacy when administered to patients with type 2 diabetes insufficiently controlled by diet and exercise and in combination with sulfonylurea.

“Adults with type 2 diabetes are often required to take more than 1 medication to manage their condition, including some that have to be taken multiple times a day,” said Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals Inc, in a press release. “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 should not be used to treat patients with type 1 diabetes or diabetic ketoacidosis. No studies have been conducted to test the treatment in patients with a history of pancreatitis.

The treatment also carries a boxed warning about the risk of lactic acidosis, which could lead to death. If patients experience cold hands or feet, dizziness, an irregular or slow heartbeat, fatigue, muscle pain, weakness, stomach pains, or nausea and vomiting, they should seek medical help immediately.

About 29 million Americans have diabetes, and 8 million go undiagnosed.