AstraZeneca announced that the European Commission has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).
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.
The EC has approved Qtrilmet to improve glycaemic control in adults with T2D when metformin with or without SU and either Onglyza or Forxiga does not provide adequate glycaemic control, or when T2D patients are already being treated with metformin, Onglyza and Forxiga.
Qtrilmet was approved in the US in May 2019 under the name Qternmet XR as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.