Reason for request
No clinical benefit demonstrated for saxagliptin in combination with metformin and a sulfonylurea
- ONGLYZA has Marketing Authorisation in combination with metformin and a sulfonylurea when dual therapy with these medicines, diet and exercise have not provided adequate glycaemic control in adult patients with type 2 diabetes.
- The fixed-dose combination KOMBOGLYZE has Marketing Authorisation in combination with a sulfonylurea, in patients not controlled by dual therapy.
- As there are no direct comparisons with validated and available triple therapies, none can be recommended in preference to any of the others.
the actual benefit of ONGLYZA is substantial in the extension of the MA indication "In combination with metformin and a sulfonylurea when this treatment alone, combined with diet and exercise, does not provide adequate glycaemic control."
Improvement in actual benefit
In the absence of a direct comparison with validated and available triple therapies, the Transparency Committee considers that ONGLYZA does not provide an improvement in actual benefit (IAB V, non-existent) in the treatment of patients with type 2 diabetes mellitus as triple oral therapy, namely, in combination with metformin and sulfonylurea when diet and exercise plus dual therapy with these medicinal products does not provide adequate glycaemic control.