Tuesday, April 3, 2007

FDA Approves Combination Drug Janumet For Type 2 Diabetes
Article Date: 03 Apr 2007 - 0:00
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US Food and Drug Administration has approved a new combination drug called Janumet that combines a new drug and an older drug in a more convenient form for people with type 2 diabetes.Janumet is made by Merck & Co and according to the company it is the first and only tablet that combines a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as Januvia), and metformin for treating patients with type 2 diabetes.Januvia, also made by Merck, enhances the body's own ability to lower elevated blood sugar. It was approved by the FDA last October and received a European Commission licence yesterday. It is mostly taken in combination with other drugs.Metformin is an oral drug in the biguanide class. It is the most widely used drug in the treatment of diabetes in the US and was first made by Bristol-Myers Squibb over ten years ago as Glucophage but has since become available in generic form.Pharma analysts are predicting that Janumet will overtake combination treatments based on Januvia because of its convenient single tablet form.According to Merck's statement, the FDA approved Janumet based "upon clinical data including sitagliptin plus metformin as separate tablets."They say that a clinical bioequivalence study has demonstrated that the single tablet Janumet is equivalent to taking sitagliptin plus metformin as separate tablets.The FDA has approved Janumet as an adjunct to diet and exercise to "improve blood sugar (glucose) control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin".Merck says that Janumet should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.The FDA announced the decision to the press late last Friday.According to the American Diabetes Association more than 6 million Americans have diabetes and don't know it. Another 54 million are pre-diabetic, with an increased risk of having the disease.The ADA give the main risk factors for type 2 diabetes as:-- being overweight-- having a sendentary lifestyle-- being over 45 years old-- having a family history of diabetesAfrican Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders carry an increased risk, as do women who give birth to babies weighing more than nine pounds (4.1 kilos).

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Written by: Catharine Paddock
Writer: Medical News Today

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