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DPP-4 Inhibitor/Metformin Combination Once-Daily Pill Kombiglyze Gains FDA Approval

In early November, Kombiglyze, a pill combining DPP-4 inhibitor Onglyza and metformin, was approved by the FDA for type 2 diabetes. Onglyza was approved in July 2010. The DPP-4 inhibitor class of drugs, which includes Merck's Januvia, Bristol-Myers Squibb/AstraZeneca's Onglyza, and Novartis' Galvus (approved outside the US), has very few side effects based on the safety data that has been shown to date. These drugs can be combined with metformin into a single combination pill (Januvia's metformin combination is called Janumet, and Galvus' metformin combination is called Eucreas). Kombiglyze represents the first DPP-4 inhibitor/metformin combination that can be taken once-daily, while Janumet and Eucreas must be taken twice-daily. Kombiglyze may also offer the additional benefit of reduced digestive discomfort because it includes a particular type of metformin, called "metformin extended-release," or metformin XR (which also enables once-daily dosing). While individual studies with different types of metformin have confirmed that metformin XR is associated with reduced digestive side effects, specific studies comparing different DPP-4 inhibitor/metformin combinations have not been conducted. We also note that the manufacturer of Janumet (Merck) is planning to submit a once-daily form of Janumet with metformin XR in the US for FDA approval before the end of 2010. In general, other than dosing and the type of metformin, Kombiglyze is largely similar to Janumet; both DPP-4 inhibitor components, Januvia and Onglyza, have demonstrated very similar safety and effectiveness in type 2 patients. For a general overview of DPP-4 inhibitors, please see the Learning Curve in diaTribe #8. For more information on programs that can make Kombiglyze more affordable, please visit AstraZeneca's Prescription Savings program.  --ST

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