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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.

   


Actual benefit

Important

Substantial


Improvement in actual benefit

V (absence)

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.