New diabetes drug enters competitive market
In a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.
Jentadueto XR combines 2.5 mg or 5 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 type 2 diabetes, 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 of 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 type 2 diabetes when treatment with both linagliptin and metformin is appropriate. “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 type 2 diabetes inadequately controlled on diet and exercise and in combination with sulfonylurea,” the manufacturers said in a statement.
However, 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 manufacturers warned. The drug’s label also 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 most common side effects of Jentadueto XR include stuffy or runny nose, sore throat and diarrhea. Serious side effects that may occur include: lactic acidosis (a build-up of lactic acid in the blood), inflammation of the pancreas (pancreatitis), hypoglycemia (especially if patients take Jentadueto XR with another medicine that can cause low blood sugar), allergic (hypersensitivity) reactions which can occur after the first dose or up to 3 months after starting Jentadueto XR and joint pain that may be severe.
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