FDA approves Kombiglyze XR for Type 2 diabetes

On 5th November 2010 the FDA approved Kombiglyze XR from BMS/AstraZeneca, for the treatment of type 2 diabetes in adults. Kombiglyze is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycaemic control across glycosylated haemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG). Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin (also known as Onglyza)and metformin is appropriate. In a 1306 patient trial of Onglyza plus meformin IR, the combination reduced HbA1c by -2.5% compared to -2.0% with metformin IR plus placebo and in a 743 patient trial with patients inadequately controlled by metformin IR, the combination showed a reduction of HbA1c of -0.7% compared to +0.1% with metformin IR plus placebo.