VOKANAMET (canagliflozin/metformin), antidiabetics

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

• INVOKANA has Marketing Authorisation in the treatment of type 2 diabetes:

- in monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance or a contraindication.

- in combination with other blood glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

• Its efficacy has been demonstrated in patients insufficiently controlled in dual therapy with metformin, in triple therapy with metformin and a sulfonylurea and in triple therapy with insulin and metformin.
• Because of its diuretic mechanism of action, caution is recommended in patients for whom a drop in blood pressure could constitute a risk. 
• VOKANAMET has Marketing Authorisation in the treatment of type 2 diabetes:

- in patients not adequately controlled by metformin alone at the maximum tolerated dose.

- in patients who have insufficient glycaemic control at the maximum dose of metformin combined with other blood glucose-lowering medicines including insulin.

- in patients already being treated with the combination of canagliflozin and metformin as separate tablets.

• The fixed-dose combination of canagliflozin/metformin has not shown any clinical benefit by comparison with the free combination of canagliflozin and metformin.