Boehringer Ingelheim and Lilly announced that the FDA has approved Jentadueto, a fixed-dose combination tablet containing linagliptin (Tradjenta; Boehringer Ingelheim and Lilly), a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin for the treatment of type 2 diabetes. This approval was based on data from clinical trials that evaluated the efficacy of the combination of linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy patients.

In a 24-week, randomized, double-blind, placebo-controlled factorial study evaluating 791 adult patients with type 2 diabetes and inadequate glycemic control with diet and exercise, linagliptin/metformin combination therapy demonstrated greater efficacy in glycemic control compared with linagliptin or metformin monotherapy and placebo. Linagliptin/metformin 2.5mg/500mg and 2.5mg/1,000mg demonstrated a -1.3% and -1.7% difference, respectively, from placebo in A1C change from baseline and a -43mg/dL and -60mg/dL difference, respectively, from placebo in fasting plasma glucose change from baseline.

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