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KOMBIGLYZE™ XR tablets approved in the US for the treatment of type 2 diabetes mellitus in adults

Publication date: 5 November 2010
Author: AstraZeneca

Tagged with: , ,

AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) approved KOMBIGLYZE™ XR for the treatment of type 2 diabetes in adults. KOMBIGLYZE XR 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. KOMBIGLYZE XR should not be used for patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in combination with insulin. Consistent with the Prescribing Information (PI) for metformin alone, the PI for KOMBIGLYZE XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with KOMBIGLYZE XR.

Once-a-day KOMBIGLYZE XR combines saxagliptin, a DPP-4 inhibitor, and metformin XR, a biguanide, in one tablet for the treatment of type 2 diabetes. KOMBIGLYZE XR should generally be administered once a day with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The maximum daily recommended dose is 5 mg for saxagliptin and 2,000 mg for metformin XR.

“Patients with type 2 diabetes in the United States can be taking four or five medications for various diseases and conditions, which can lead to complicated medication schedules,” said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca. “KOMBIGLYZE XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.”

The Centers for Disease Control and Prevention (CDC) estimate that approximately one in every 11 adults in the United States has diagnosed diabetes. Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults.

The co-administration of saxagliptin and metformin has been well-studied in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve patients inadequately controlled on diet and exercise alone. There have been no clinical efficacy or safety studies conducted with KOMBIGLYZE XR. Relative bioavailability between KOMBIGLYZE XR and coadministered saxagliptin and metformin immediate-release (IR) tablets has not been conducted.

The FDA approved once-a-day KOMBIGLYZE XR based on two Phase III clinical trials and bioequivalence studies. The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared to placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between KOMBIGLYZE XR and saxagliptin plus metformin XR as separate tablets.

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