by Dr. Sania Siddiqui on  May 10, 2011 at 2:45 PM Health Watch
Diabetes Type 2 - New Once a Day Drug Linagliptin Approved by FDA
The US Food and Drug Administration (FDA) recently approved linagliptin (Tradjenta) for improving blood glucose levels in adults with type 2 diabetes, either as a stand-alone or in combination with other therapies.

This DPP-4 inhibitor was developed by Eli Lilly and Boehringer Ingelheim and will be marketed under the brand name of Tradjenta.

The FDA reports that 8 double-blind, placebo-controlled clinical trials in 3,800 subjects demonstrated the drug to be safe and effective in patients with type 2 diabetes. The drug has been studied as a monotherapy and in combination with other drugs as well.

Like other DPP-4 inhibitors, linagliptin can be taken in combination with other diabetes drugs, such as metformin. However, its use with insulin has yet to be tested.

Mary Parks, MD, Director of the FDA's Division of Metabolism and Endocrinology Products says in a recent news release, "This approval provides another treatment option for the millions of people with type 2 diabetes. It is equally effective when used alone or when added to existing treatment regimens."

Tradjenta stimulates the release of insulin after a meal by blocking a specific chemical messenger in intestinal cells. This keeps blood sugar levels from shooting up while posing little risk of sudden drop in blood sugar (hypoglycemia).

Clinicians are advised not to prescribe the drug in patients with type 1 diabetes or those who have diabetic ketoacidosis. The most common side effects of linagliptin are upper respiratory infection (URI), sore throat, stuffy or runny nose, headache, muscle pain.

It will be sold with an FDA required "Patient Package" explaining the drug's uses and risks.

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Source: Medindia

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