AstraZeneca combo diabetes drug Qtrilmet approved in Europe

The European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycemic control in adults with type-2 diabetes (T2D), says Cambridge, UK-based AstraZeneca (LSE: AZN).

The approval is based on data from five Phase III trials which evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of 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 reducing HbA1c compared to Forxiga with metformin, Onglyza with metformin, or glimepiride (an approved T2D sulphonylurea (SU) medicine) with metformin. The combination of Forxiga, Onglyza and metformin with or without glimepiride showed non-inferiority in reducing HbA1c versus 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.