XIGDUO (dapagliflozin/metformin), antidiabetic
Reason for request
- XIGDUO has Marketing Authorisation in the treatment of type 2 diabetes in adults:
- in patients not adequately controlled with metformin alone at the maximum tolerated dose.
- in combination with other blood-glucose lowering medicines, including insulin, in patients not adequately controlled with metformin and those medicines,
- in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
- Given the safety profile and modest efficacy of dapagliflozin, the fixed combination has shown no clinical benefit in the management of type 2 diabetes.