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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.