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FDA approves metformin/saxagliptin combination for type 2 diabetes

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The once-daily metformin extended-release plus dipeptidyl peptidase-4 tablet demonstrated significant reductions in HbA1c levels, fasting plasma glucose and postprandial glucose, according to a company press release.

The combination therapy (Kombiglyze XR; Bristol-Myers Squibb, AstraZeneca) is indicated in conjunction with diet and exercise for adults with type 2 diabetes but has not been studied in combination with insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

FDA approval is based on two phase 3 trials and bioequivalence studies that demonstrated the safety and efficacy of metformin and saxagliptin (Onglyza; Bristol-Myers Squibb, AstraZeneca) as separate tablets. The current tablet, which combines the two drugs, should be administered once daily with the evening meal and should be titrated to reduce metformin-associated gastrointestinal adverse events. The maximum daily recommended dose is 5 mg saxagliptin and 2,000 mg metformin ER, according to the press release.

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