Reason for request
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.
- Substantial as dual therapy in combination with metformin
- Substantial as triple therapy in combination with metformin and a sulfonylurea
- Moderate as triple therapy in combination with metformin and insulin
- Insufficient as monotherapy
- Insufficient as dual therapy in combination with sulfonylureas or insulin
Improvement in actual benefit
In the indications as dual therapy with metformin, and as triple therapy with metformin and a sulfonylurea or with metformin and insulin:
Taking into account the evidence that canagliflozin is non-inferior to its active comparators, the lack of evidence of its superiority to sitagliptin for the 100 mg dosage, and the lack of long-term safety data, the Committee considers that the INVOKANA proprietary medicinal products do not provide any improvement in actual benefit (level V, non-existent) in the management of patients with poorly controlled type 2 diabetes, as dual oral therapy in combination with metformin and as triple therapy in combination with metformin and a sulfonylurea or in combination with metformin and insulin.
In the indications as monotherapy, and as dual therapy in combination with sulfonylureas or insulin: