The Food and Drug Administration has approved linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, the agency announced in a May 2 statement.
Linagliptin, in a tablet formulation, is approved for improving blood glucose control in adults with type 2 diabetes, in combination with diet and exercise. In eight double-blind, placebo-controlled studies of about 3,800 patients with type 2 diabetes, those treated with linagliptin showed improvements in blood glucose control compared to those on placebo, according to the statement.
Linagliptin has been studied alone or in combination with other drugs used to treat type 2 diabetes, including metformin, glimepiride, and pioglitazone, the statement said. It will be marketed as Tradjenta, by Boehringer Ingelheim Pharmaceuticals and Eli Lilly.
At press time, neither company had posted a news release announcing the approval.