Kombiglyze XR tablets approved for the treatment of type 2 diabetes mellitus in adults

November 8, 2010

FDA has approved saxagliptin and metformin extended-release (XR) (Kombiglyze XR, AstraZeneca/Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels, fasting plasma glucose, and postprandial glucose.

FDA has approved saxagliptin and metformin extended-release (XR) (Kombiglyze XR, AstraZeneca/Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across glycosylated hemoglobin levels, fasting plasma glucose, and postprandial glucose.

Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin (also known as Onglyza) and metformin is appropriate.

FDA approved once-a-day saxagliptin and metformin XR based on 2 phase 3 clinical trials and bioequivalence studies. The 2 clinical studies evaluated the efficacy and safety of saxagliptin and metformin immediate-release (IR) as separate tablets compared to placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between saxagliptin and metformin XR and saxagliptin plus metformin XR as separate tablets.

“Type 2 diabetes is not only an epidemic, but as time passes it is: harder to control; associated with more complications; and therefore is a disease that gets more, not less, expensive as people live longer with their complications,” said Naomi Neufeld, MD, FACE, medical director at KidShape Foundation, a Los Angeles-based non-profit organization that builds healthy families. “This drug may help to show a reduction in the complication rate, by making control easier to achieve. That in turn should reduce associated costs.”