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FDA approves triple combination therapy for type 2 diabetes
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The FDA on Thursday approved a once-daily, extended-release combination of the SGLT2 inhibitor dapagliflozin, the DPP-IV inhibitor saxagliptin and metformin for the treatment of type 2 diabetes, according to a press release from AstraZeneca.
The oral combination therapy (Qternmet XR) is approved in two fixed doses (dapagliflozin/saxagliptin/metformin 5 mg/5 mg/1,000 mg and 10 mg/5 mg/2,000 mg) and is intended for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control.
The approval is based on two phase 3 trials, which evaluated combinations of dapagliflozin (Farxiga) and saxagliptin (Onglyza) in adults with poorly controlled type 2 diabetes prescribed metformin.
In one trial, treatment with 5 mg dapagliflozin plus 5 mg saxagliptin in addition to metformin demonstrated decreases in HbA1c and an increase in the number of patients achieving the recommended HbA1c treatment goal of less than 7%. In the second trial, treatment with 10 mg dapagliflozin plus 5 mg saxagliptin in addition to metformin extended-release demonstrated decreases in HbA1c and an increase in the number of patients achieving an HbA1c of less than 7%.
The safety results of the individual medicines in these trials were consistent with their known profile, according to the release.
A once-daily combination of dapagliflozin and saxagliptin without metformin was approved by the FDA in February 2017. That combination therapy (Qtern) is indicated for patients with type 2 diabetes inadequately controlled with dapagliflozin or who are already treated with both dapagliflozin and saxagliptin therapy.