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FDA Approves Type 2 Diabetes Treatment

Diabetes Test (NIH)

(National Institutes of Health)

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, which when used with diet and exercise, can improve blood glucose control in adults with Type 2 diabetes. Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, and Eli Lilly Company in Indianapolis, Indiana.

People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Type 2 diabetes is the most common form of the disease, affecting between 90 and 95 percent of the 24 million people in the U.S. with diabetes. 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 or DPP-4, which leads to better blood glucose control. The drug has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. However, FDA says 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 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. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Read more: Eli Lilly, Boehringer Ingelheim to Partner on Diabetes Drugs

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