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AstraZeneca's Qtrilment scores European authorisation in type 2 diabetes

Published on 15/11/19 at 11:02am

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) has secured approval in Europe, its manufacturer AstraZeneca has revealed, as a therapy to improve glycaemic control in adults with type-2 diabetes (T2D).

Specifically, the approval covers T2D patients who have not experienced adequate glycaemic control with metformin with or without sulphonylurea and in combination with either Onglyza or Forxiga, or in patients who are already receiving treatment with metformin, Onglyza and Forxiga.

Data from five Phase 3 trials supporting the application demonstrated that the combination of Forxiga (dapagliflozin) and Onglyza (saxagliptin), when used alongside metformin in patients with inadequately controlled type 2 diabetes, proved superior in reducing blood glucose levels compared to metformin paired with either Forxiga, Onglyza, or glimepiride.

This superior combo, with or without glimepiride, also proved itself non-inferior to the combination of insulin and metformin with or without glimepiride in blood glucose level reduction.

The European decision follows the drug’s US approval in March this year.

Matt Fellows

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