The European Commission has granted approval to AstraZeneca's Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-two diabetes (T2D), it was reported yesterday that.

The approval is based on data from five Phase III trials that assessed combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) based on metformin in patients with inadequately controlled T2D. The primary endpoint in these trials was mean change from baseline in HbA1c (average blood glucose levels) at week 24 or 52. Across the trials, the combination of Forxiga, Onglyza and metformin was superior at decreasing HbA1c compared to Forxiga with metformin, Onglyza with metformin, or glimepiride (an approved T2D sulphonylurea (SU) medicine) with metformin.

The integration of Forxiga, Onglyza and metformin with or without glimepiride indicated non-inferiority in decreasing HbA1c compared to the combined use of insulin and metformin with or without glimepiride. The safety results of the individual medicines in these trials were consistent with their known profile.