AstraZeneca reports approval of Qtrilmet by EU for the treatment of type-2 diabetes.
NORDIC BUSINESS REPORT-November 18, 2019-AstraZeneca reports approval of Qtrilmet by EU for the treatment of type-2 diabetes
(C)2019 M2 COMMUNICATIONS http://www.m2.com
AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, reported on Friday the approval by the European Commission (EC) of Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).
This 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 these 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...
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