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New diabetes drug approved by the FDA

May 3, 2011
A drug that improves blood glucose levels in adults with type 2 diabetes has been approved by the U.S. Food and Drug Administration (FDA), the agency announced.

Tradjenta (linagliptin) tablets, manufactured by Indianapolis-based Eli Lilly Company, are most effective when coupled with diet and exercise. "This approval provides another treatment option for the millions of Americans with type 2 diabetes," said Dr. Mary Parks, a director in the FDA’s Center for Drug Evaluation and Research. "It is effective when used alone or when added to existing treatment regimens."

Tradjenta works by increasing hormones that stimulate insulin released in the body after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which helps control blood glucose levels. It was successfully tested in clinical studies that included about 3,800 patients with type 2 diabetes.

The drug's most common side effects include upper respiratory infection, stuffy or runny nose, sore throat, muscle pain and headache.

Glen Cove Hospital, part of the North Shore-LIJ Health System, was the first New York hospital to be certified for Advanced Inpatient Diabetes Management by the Joint Commission, a national accreditation organization.
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