Merck announced that expanded labeling has been approved for Januvia (sitagliptin), the only DPP-4 inhibitor indicated domestically as an adjunct to diet and exercise to improve glycemic control in adult type 2 diabetics.


The new regimens with Januvia described in the labeling update include (in addition to diet and exercise) initial therapy in combination with metformin; add-on therapy to a sulfonylurea (glimepiride) when that agent alone does not provide adequate blood glucose control; and add-on therapy to the combination of glimepiride and metformin when dual therapy does not achieve sufficient glycemic control.

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The Warnings and Precautions section of the labeling was updated to include post-marketing reports of anaphylaxis, angioedema, and exfoliative skin conditions in patients treated with the drug. The recommended dose of Januvia is 100 mg once daily, with or without food, for all approved indications.