FDA Approves Linagliptin/Metformin Combo For Type 2 Diabetes


The Food and Drug Administration on Jan. 30 approved a type 2 diabetes therapy that combines linagliptin and metformin in a single tablet taken twice daily.*

The approval was announced by Eli Lilly and Boehringer Ingelheim. The companies jointly developed the tablet, to be marketed as Jentadueto. Linagliptin is a dipeptidyl peptidase–4 (DPP-4) inhibitor that was approved for marketing in May 2011.

The linagliptin/metformin combination is intended to be used in conjunction with diet and exercise to improve glycemic control. Jentadueto was approved based on a 24-week, double-blind, placebo-controlled study that compared six arms: placebo, linagliptin once daily; 500 mg metformin twice daily; 2.5 mg linagliptin plus a 500-mg tablet of metformin twice daily; 1,000 mg metformin twice daily; and 2.5 mg linagliptin plus 1,000 mg metformin twice daily.

The actual combination tablet was not tested, but the FDA approved it based on bioequivalence studies, according to Lilly. The 2.5-mg linagliptin plus 1,000-mg metformin arm had the best results, reducing hemoglobin A1c by up to 1.7%. The two tablets did not cause any meaningful changes in body weight, according to a company statement.

Lilly said that Jentadueto can be used alone or in combination with a sulfonylurea. It is not indicated for type 1 diabetes or diabetic ketoacidosis. Jentadueto has a boxed warning for the risk of lactic acidosis.

*Correction, 1/31/12: An earlier version of this story noted the incorrect approval date.

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