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KOMBOGLYZE (saxagliptin/metformin), antidiabetic
DIABETOLOGY - New indication
Opinions on drugs -
Posted on
Feb 25 2015
Reason for request
Extension of indication
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.
Clinical Benefit
| Substantial |
Substantial |
Clinical Added Value
| no clinical added value |
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. |
