FDA OKs Linagliptin/Metformin Combo for Type 2 Diabetes

Miriam E. Tucker

May 31, 2016

The US Food and Drug Administration (FDA) has approved a once-daily oral combination of linagliptin and metformin hydrochloride (Jentadueto XR, Boehringer Ingelheim and Eli Lilly & Co) for treating adults with type 2 diabetes.

The tablets combine 2.5 mg or 5.0 mg of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin with 1000 mg of metformin. The indication is as an adjunct to diet and exercise in adults with type 2 diabetes in whom treatment with the individual agents is appropriate. The drug should not be used in people with type 1 diabetes or diabetic ketoacidosis and has not been studied in people with a history of pancreatitis.

The Jentadueto label will contain a boxed warning about the risk for lactic acidosis from the metformin component.

The safety and efficacy of Jentadueto XR have been established on the basis of "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," according to a statement from the Boehringer Ingelheim-Lilly Diabetes alliance.

When on the US market, the new agent will join other extended-release DPP-4 inhibitor/metformin combinations, including sitagliptin and extended-release metformin hydrochloride (Janumet XR, Merck) and saxagliptin and extended-release metformin hydrochloride (Kombiglyze XR, Bristol-Myers Squibb/AstraZeneca).

Asked to comment, American Diabetes Association President Desmond Schatz, MD, told Medscape Medical News, "There is a definite need to improve control in type 2 diabetes. Combination therapy, hopefully, both early and later in the disease, can improve control. Nobody likes to take a lot of drugs, so I think simplifying the regime may help."

Dr Schatz has disclosed no relevant financial relationships.


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