Reason for request

Inclusion

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.

Clinical Benefit

Substantial

-       Substantial as dual therapy in combination with metformin

-       Substantial as triple therapy in combination with metformin and a sulfonylurea

Moderate

-      Moderate as triple therapy in combination with metformin and insulin

Insufficient

-       Insufficient as monotherapy

-       Insufficient as dual therapy in combination with sulfonylureas or insulin


Clinical Added Value

no clinical added value

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:

Not applicable.

Not applicable