A once-daily tablet for type 2 diabetes, which combines three different types of medication, has received European approval.
The European Commission has given permission for AstraZeneca’s Qtrilmet to be used among adults with type 2 diabetes who meet certain criteria.
The drug combines metformin hydrochloride, saxagliptin and dapagliflozin. Metformin is a widely prescribed drug which helps to improve insulin sensitivity. Saxagliptin (trade name Onglyza) is a dipeptidyl peptidase-4 (DPP-4) inhibitor drug that also helps improve insulin sensitivity. Dapagliflozin (trade name Forxiga) is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor which helps the kidneys expel excess glucose out of the blood.
The combination drug was approved in the US in May. In the US, the drug is marketed under the trade name Qternmet XR.
The approval was based on data from five trials in which the drug showed superior performance compared with three rival medications that were also combination drugs for type 2 diabetes.
Qtrilmet also demonstrated non-inferiority compared with insulin and metformin.
The drug will be available in two different doses. One dose will have a slightly higher concentration of metformin than the other dose available. Both forms of the drug will be modified-release tablets, which can help to minimise side effects.
The possible side effects include upper respiratory tract infections and gastrointestinal symptoms. If the medication is used alongside insulin or a sulphonylurea, there is a greater risk of hypoglycemia.
In a statement, the AstraZeneca board said: “The EC has approved Qtrilmet to improve glycemic control in adults with type 2 diabetes when metformin with or without sulphonylurea and either Onglyza or Forxiga does not provide adequate glycemic control, or when type 2 diabetes patients are already being treated with metformin, Onglyza and Forxiga.”