New incretin-based therapy should be used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
The FDA announced Monday it had approved the incretin therapy Tradjenta (linagliptin) to be used in conjunction with diet and exercise to lower blood sugar in adults with type 2 diabetes.
In a news release, the FDA announced that Tradjenta “was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.”
Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies, including metformin, glimepiride, and pioglitazone, but has not been studied as part of combination therapy with insulin. Tradjenta should not be used to treat people with Type 1 diabetes or in those who have diabetic ketoacidosis.
Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said, “This approval provides another treatment option for the millions of Americans with Type 2 diabetes. It is effective when used alone or when added to existing treatment regimens.”
A news release from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company noted that clinical trials, Tradjenta had “demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent” compared to placebo.
Additional facts about Tradjenta:
John Gerich MD, professor of medicine, University of Rochester School of Medicine, said, “Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications. The FDA approval of Tradjenta is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. With Tradjenta, physicians will have another option for managing type 2 diabetes, [which is] a potentially devastating condition.”