Medication Monitor

Generic Name (Trade Name—Company)
May 30, 2019

Dapagliflozin, saxagliptin, and metformin hydrochloride

(Qternmet XR—AstraZeneca)
Combination agent approved for treatment of type 2 diabetes

FDA approved dapagliflozin, saxagliptin, and metformin hydrochloride extended-release tablets under the trade name Qternmet XR as a once-daily, oral medicine adjunct treatment to diet and exercise to improve glycaemic control in adults with type 2 diabetes (T2D).

Approval was based on two Phase III trials that evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks in patients with inadequately controlled T2D. The safety results of the individual medicines in these trials were consistent with their known profile.