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XIGDUO (dapagliflozin/metformin), antidiabetic

DIABETOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 03 2016

Reason for request


No clinical benefit demonstrated in the management of patients with type 2 diabetes

  • 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.



Clinical Benefit




Therapeutic use


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