KOMBOGLYZE (saxagliptin/metformin), antidiabetic
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.
Improvement in actual benefit
As there are no direct comparisons with the validated triple therapies available and no clinical trials conducted with the fixed-dose combination, the Transparency Committee considers that KOMBOGLYZE does not provide any improvement in actual benefit (level V, non-existent) in the management of type 2 diabetes patients as triple oral therapy in combination with a sulfonylurea.