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.
Clinical Benefit
Moderate
Monotherapy : Insufficient for reimbursement by National Health Insurance Dual therapy : - with metformin : Moderate
Tritherapy : - with metformin and a sulfonylurea : Moderate - with insulin and metformin : Moderate
Insufficient
- with a sulfonylurea : Insufficient for reimbursement by National Health Insurance - with insulin : Insufficient for reimbursement by National Health Insurance
Clinical Added Value
no clinical added value
In the indications as dual therapy with metformin, and as tritherapy with metformin and a sulfonylurea or with metformin and insulin : In light of the available clinical data, namely placebo-controlled studies with empagliflozin 10 or 25 mg/day when active comparators are available and modest results from a sequential non-inferiority and superiority study of empagliflozin at its maximum dose of 25 mg/day versus an active comparator, the sulfonylurea glimepiride, at doses of 1 to 4 mg/day (whereas its maximum dose is 6 mg/day), the Committee considers that the JARDIANCE 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 tritherapy in combination 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.
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