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Oct 17, 2006

First DPP-4 Inhibitor in the U.S. Approved for Type 2 Diabetes

  • Merck & Co.’s Januvia™ (sitagliptin phosphate), which the company says is the first and only DPP-4 inhibitor available in the U.S. for the treatment of type 2 diabetes, received approval. Januvia acts by enhancing a natural body system to lower elevated blood sugar, the company explains.

    “Those patients who are unable to adequately manage their type 2 diabetes with lifestyle changes, like healthy eating and increased physical exercise, and who require medications now have a new product to help regulate their blood sugar levels,” points out Edward S. Horton, M.D., consultant for Merck & Co., as well as director of clinical research, Joslin Diabetes Center and professor of medicine, Harvard Medical School.

    Januvia has been approved as a monotherapy and as an add-on to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs). The recommended dose is 100 mg once daily. Merck & Co, asserts that the drug should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis.

    Januvia enhances the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, Januvia works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.

    Merck & Co. explains that since Januvia’s mechanism of action is glucose-dependent, it lowers the potential for hypoglycemia. Treatment with Januvia was also not associated with weight gain. The company reports that the most common side effects with Januvia (greater than or equal to 5% and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.


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