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FDA approves updated linagliptin label
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The FDA has approved a supplemental drug application for linagliptin tablets for use as an add-on therapy to insulin in patients with type 2 diabetes and for use in patients with type 2 diabetes who also have severe chronic renal impairment.
Linagliptin (Tradjenta, Boehringer Ingelheim) was approved in 2011 to be used in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes. According to a news release from the manufacturer, linagliptin should still not be used in patients with type 1 diabetes or for the treatment of ketoacidosis.
The approval comes after a 52-week, phase 3 trial demonstrated the efficacy of linagliptin in combination with insulin (with or without metformin and/or pioglitazone), according to the release.
Additional data from a 52-week double blind, randomized, controlled clinical trial involving patients with severe chronic renal impairment showed that linagliptin 5 mg and other glucose-lowering therapies provided statistically significant improvements to HbA1c levels compared with placebo.