The study has reached the primary endpoint and has shown consistent safety results of the individual medicines with their known profile

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Image: AstraZeneca research and analysis facility in China. Photo: Courtesy of AstraZeneca.

AstraZeneca has secured the European Commission (EC) approval for its Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets, used for improving glycaemic control in adults with type-2 diabetes (T2D).

Qtrilmet is a once-daily oral medicine indicated as a treatment in adults with T2D, and it comprises selective sodium‑glucose co-transporter 2(SGLT2) inhibitor Forxiga, dipeptidyl peptidase‑4 (DPP‑4) inhibitor Onglyza and metformin hydrochloride.

The pharma company said that the approval is based on data from five Phase III trials designed to evaluate the combination of Forxiga (dapagliflozin) and Onglyza (saxagliptin) along with metformin in patients with inadequately controlled T2D.

Forxiga, Onglyza and metformin combination helped in reducing HbA1c

In the study, the combination of Forxiga, Onglyza and metformin has shown superiority in reducing HbA1c compared to the combinations Forxiga with metformin, Onglyza with metformin, or glimepiride with metformin.

Also, the combination of three drugs with or without glimepiride has demonstrated non-inferiority in reducing HbA1c compared to the combined use of insulin and metformin with or without glimepiride.

The study has reached the primary endpoint, mean change from baseline in HbA1c at week 24 or 52, and the study showed consistent safety results of the individual medicines with their known profile.

In October 2019, the company has secured the US Food and Drug Administration (FDA) approval for its Farxiga (dapagliflozin) indicated to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D).

FDA has approved Farxiga, based on results from the DECLARE-TIMI 58 CV outcomes trial (CVOT), to evaluate T2D patients with multiple CV risk factors or established CV disease, said the company.

Besides, DECLARE-TIMI 58 marks the largest sodium-glucose cotransporter2 (SGLT2) inhibitor CVOT to be conducted till date.

AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber said: “Farxiga is he first SGLT2 inhibitor approved in the US to reduce the risk of hospitalisation for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors.

“This is promising news for the 30 million people living with type-2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalisation for heart failure.”