The Food and Drug Administration has approved the expanded use of diabetes drug Januvia (sitagliptin), giving its blessing to use of the DPP-4 inhibitor in combination with several other drugs for treating type 2 diabetes.

Januvia was originally approved by the FDA just a year ago for use either alone, or as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve glucose control in patients with type 2 diabetes when diet and exercise are not enough.

One supplemental application approved on October 17th okayed the use of Januvia as an adjunct to diet and exercise in combination with metformin as initial therapy to improve glycemic control, according to Merck and Co., the drug's developer.

The other supplemental application approved authorizes use of Januvia, as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea when the single agent alone does not provide adequate glycemic control.

The FDA also approved Januvia as add-on therapy to the combination of a sulfonylurea plus metformin when dual therapy does not provide adequate glycemic control.

"The substantial A1C reductions that are seen when Januvia is used in combination with metformin as first-line therapy in patients with type 2 diabetes are meaningful to me as a clinician," said Dr. Barry J. Goldstein, director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College, Philadelphia, PA.

"The data show that this approach helped many patients achieve their A1C goal and the rate of gastrointestinal side effects was similar to that seen with metformin alone," Goldstein added.