Reason for request
No clinical benefit demonstrated in dual therapy with metformin or in triple therapy with metformin/sulfonylurea or metformin/insulin in the management of type 2 diabetic patients inadequately controlled with metformin, or with a combination of metformin and a sulfonylurea or metformin and insulin
No clinical benefit in monotherapy or in dual therapy with a sulfonylurea or insulin
- JARDIANCE has Marketing Authorisation in the treatment of type 2 diabetes in monotherapy and in combination with other blood glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
- The available clinical data are based mainly on studies versus placebo, whereas active comparators do exist. Just one study has shown modest efficacy for JARDIANCE 25 mg/day versus glimepiride (sulfonylurea) 1-4 mg/day whereas its maximum dose is 6 mg/day.
Monotherapy : Insufficient for reimbursement by National Health Insurance
- with a sulfonylurea : Insufficient for reimbursement by National Health Insurance
Improvement in actual benefit
In the indications as dual therapy with metformin, and as tritherapy with metformin and a sulfonylurea or with metformin and insulin :
In the indications as monotherapy, and as dual therapy with sulfonylureas or insulin : Not applicable.