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FDA Approves 3 New Drugs for Type 2 Diabetes
Date:1/28/2013

FRIDAY, Jan. 25 (HealthDay News) -- The U.S. Food and Drug Administration late Friday approved three new medications to help people battle type 2 diabetes.

All three drugs contain a new active ingredient, alogliptin, either alone or in combination with other, previously approved medications. The newly approved drugs include Nesina (alogliptin), Kazano (alogliptin plus metformin) and Oseni (alogliptin plus pioglitazone), the FDA said in a news release.

"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in the statement. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."

More than 24 million people in the United States are currently affected by type 2 diabetes, which is closely linked with obesity. In the type 2 form of the disease, people gradually develop resistance to insulin or fail to produce enough of the hormone, resulting in rising blood sugar levels. That can lead to other health problems, such as heart disease, vision problems and neural or kidney dysfunction.

The FDA urges that the new medications be used in combination with a healthy diet and exercise to help bring diabetes under control. All of the drugs underwent study either as stand-alone products or used alongside standard diabetes medications such as sulfonyureas or insulin.

In the case of Nesina, the drug showed safety and effectiveness across 14 clinical trials, involving more than 8,500 patients, according to the FDA. The most common side effects included stuffy or runny nose, headache, and upper respiratory tract infections.

Kazano's safety and effectiveness were tested in four clinical trials involving more than 2,500 patients. Side effects included those seen with Nesina, as well a
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