The European Commission (EC) has approved AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) for adults with type II diabetes.
The company announced that the modified-release tablets, given to improve glycaemic control, were approved by the committee 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 disease.
The primary endpoint in these trials, which was met, was mean change from baseline in HbA1c (average blood glucose levels) at week 24 or 52.
The drug combo was found to be superior at reducing HbA1c compared to Forxiga with metformin, Onglyza with metformin, or glimepiride with metformin. Further, 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, and the safety results of the individual medicines in these trials were consistent with their known profile.
The therapy, a once-daily oral medicine, was initially 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 type II diabetes.
This World Diabetes Day (November 14th), a new survey conducted by Merck and YouGov found that there is a need to better educate people on the risk factors of type II diabetes. The research revealed that more than half of the public are not aware the condition may be preventable, and that just under half are unaware of the steps that can be taken to prevent or delay the development of it.
Merck says that the “alarming” results “demonstrate that more needs to be done to raise awareness of diabetes and its causes. With close to 700 million people predicted to develop type II diabetes by 2045, we need to act now to address prediabetes and help prevent a disease that can cause many long-term and permanent complications for people.”
In August the NHS announced the roll out of digital diabetes prevention as part of NHS Long Term Plan, providing ‘thousands’ of people at risk of Type II diabetes digital support to prevent them developing the condition.