FDA approves new treatment for type 2 diabetes

FDA approved linagliptin (Tradjenta, Boehringer Ingelheim and Eli Lilly) tablets, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.

People with type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 (DPP-4), which leads to better blood glucose control.

"Tradjenta tablets are an exciting new option to help patients manage their type 2 diabetes as it is the first DPP-4 inhibitor approved at one dosage strength,” John Gerich MD, professor of medicine, University of Rochester School of Medicine, told Drug Topics. “It may be an appropriate option for people with type 2 diabetes who have not yet been able to achieve their treatment goals, or may also help people with this condition who have not reached their treatment goals with metformin alone.”

Type 2 diabetes is the most common form of the disease, affecting between 90% and 95% of the 24 million people in the United States with diabetes. Tradjenta was demonstrated to be safe and effective in 8 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. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug's uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.