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New Combination Drug Approved

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On November 5, the US Food and Drug Administration (FDA) approved the combination oral diabetes medicine Kombiglyze XR, a joint development of Bristol-Myers Squibb and AstraZeneca, for use in people with Type 2 diabetes. Kombiglyze XR combines saxagliptin (brand name Onglyza), a DPP-4 inhibitor, and extended-release metformin (Glucophage XR and others).

DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions. Metformin works by decreasing the amount of glucose made by the liver and by improving insulin sensitivity in the liver, muscle, and fat cells.

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Kombiglyze XR will be offered in doses of 5 milligrams of saxagliptin/500 milligrams of metformin, 5 milligrams of saxagliptin/1,000 milligrams of metformin, and 2.5 milligrams of saxagliptin/1,000 milligrams of metformin to be taken once daily with food. (The maximum recommended doses are 5 milligrams of saxagliptin and 2,000 milligrams of metformin, respectively.) It is approved for use as an adjunct to diet and exercise in adults with Type 2 diabetes.

This medicine should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), and it has not been studied in combination with insulin. Because of the inclusion of metformin, Kombiglyze XR carries the risk of a rare but serious metabolic complication known as lactic acidosis. Common side effects of this medicine include upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

For more information about Kombiglyze XR, see the press release on the AstraZeneca Web site.

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