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FDA Approves Tradjenta for the Treatment of Type 2 Diabetes in Adults
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:
- Is a dipeptidyl peptidase-4 (DPP-4) inhibitor
- First member in this class to be approved at one dosage strength (5 mg, once daily)
- No dose adjustment needed for patients with kidney or liver impairment
- Tablet formulation can be taken with or without food
- In trials, Tradjenta “showed statistically significant A1C reductions of up to 0.7 percent when used as monotherapy”
- Tradjenta used in combination with metformin, sulfonylurea, and metformin plus sulfonylurea resulted in “significant A1C reductions of 0.6, 0.5, and 0.6 percent, respectively”
- Tradjenta plus pioglitazone produced “significant reductions in A1C of 0.5 percent”
- Treatment with Tradjenta resulted in “significant reductions in fasting plasma glucose” when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone
- Produced “produced significant reductions in two-hour post-prandial glucose” when used as monotherapy and when used in combination with metformin
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.”
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