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Phase 3b linagliptin trial initiated in type 2 diabetes, albuminuria

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Boehringer Ingelheim and Eli Lilly have announced the initiation of a phase 3b trial of linagliptin in patients with type 2 diabetes and prevalent albuminuria. The primary endpoint is the change in baseline HbA1c after 24 weeks of treatment.

According to a company press release, the completion of the 24-week, multicenter, multinational, randomized, double blind, placebo-controlled, parallel-group trial is expected in 2014.

Researchers will test the glycemic efficacy of once-daily linagliptin (Tradjenta; Boehringer Ingelheim, Eli Lilly) 5 mg in patients with micro- or macroalbuminuria (defined as 30 mg/g to 3,000 mg/g creatinine). The study drug will be given in combination with current standard treatment of diabetic nephropathy with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.