The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.
Linagliptin is a dipeptidyl peptidase-4 or DPP-4 enzyme inhibitor. Thus it prevents the degradation of the incretins and ultimately increase the level of insulin after a meal.
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. 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).
The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.
Other DPP-4 inhibitors in the market are Sitagliptin and Vildagliptin.
Exenatide is the incretin mimetic available as a drug.
The DPP-4 inhibitors and incretin mimetics are approved for use alongwith diet control and exercise.
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