dapagliflozin + metformin (Xigduo)

following an abbreviated submission:

dapagliflozin plus metformin (Xigduo®) is accepted for restricted use within NHS Scotland.

Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

• in patients inadequately controlled on their maximally tolerated dose of metformin alone;
• in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products;
• in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.

SMC restriction: to use in patients for whom a combination of dapagliflozin and metformin is an appropriate choice of therapy i.e.
• when metformin alone does not provide adequate glycaemic control and a sulphonylurea is inappropriate.
• in combination with insulin, when insulin and metformin does not provide adequate control.
• in combination with a sulphonylurea, when a sulphonylurea and metformin does not provide adequate control.  

Dapagliflozin in combination with metformin has been shown to be bioequivalent to dapagliflozin and metformin administered separately and dapagliflozin administered twice daily has been shown to provide similar exposure to the equivalent dose administered once daily.