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BYETTA (exenatide), antidiabetic

DIABETOLOGY - New indication
Opinions on drugs - Posted on Feb 23 2015

Reason for request

extension of indication

No clinical benefit demonstrated in combination with a basal insulin and metformin

 

  • BYETTA has Marketing Authorisation in triple therapy, in combination with a basal insulin and metformin in adults who have not achieved adequate glycaemic control with these medicinal products in triple therapy.
  • This use is set down in a specialist opinion justifying the escalation of treatment for the management of type 2 diabetes.

Clinical Benefit

Substantial

Substantial in the treatment of type 2 diabetes as adjunctive therapy to basal insulin with metformin in adults who have not achieved adequate glycaemic control with these agents.


Clinical Added Value

no clinical added value

In combination with basal insulin and metformin in patients with type 2 diabetes inadequately controlled by these medicines, taking into account the data available, namely a non-inferiority study of exenatide versus insulin lispro, BYETTA does not provide any improvement in actual benefit (level V, non-existent).