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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). |
