Saxagliptin/Metformin Combo Pill Approved By FDA

The Food and Drug Administration (FDA) in the US has given approval for a combination pill featuring saxagliptin and extended-release (XR) metformin HCl to treat glycemic control in adults suffering from type 2 diabetes mellitus.

The combined pill, which is taken once a day, provides an alternative treatment for those nearly half of adult diabetes patients who are unable to control blood sugar levels . The approval was based on findings from two double-blind, 24-week, phase 3 clinical trials of saxagliptin and metformin immediate-release (IR), which were given as separate tablets, and compared with metformin IR alone.

Howard Hutchinson, chief medical officer at AstraZeneca, who developed the treatment, commented “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. Kombiglyze XR combines two effective diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.”

The combination incorporates the complimentary mechanisms of saxagliptin, which is a dipeptidyl peptidase 4 inhibitor, with metformin, a biguanide . The therapy fights against the main defects in type 2 diabetes by increasing insulin secretion in a glucose-dependent manner, suppressing hepatic gluconeogenesis, and also helping insulin sensitivity.

As type 2 diabetes is a chronic, progressive disease with many factors involved in its development, patients often need more than one pill to treat the multiple defects associated with the disease.

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