BYDUREON (exenatide), antidiabetic
DIABETOLOGY - New indication
Opinions on drugs -
Posted on
Dec 18 2018
Reason for request
Extension of indication
Insufficient clinical benefit to justify reimbursement for type 2 diabetes in combination with basal insulin with or without metformin
BYDUREON now has MA in combination with a basal insulin for type 2 diabetes patients having failed to achieve adequate glycaemic control.
Its efficacy on HbA1c variation has only been compared versus placebo, in combination with insulin glargine ± metformin, eventhough a comparison versus a clinically relevant comparator was feasible and all other GLP1 analogues have been compared to an active comparator.
The effect size of BYDUREON versus placebo appears to be modest.
- There is no evidence of a reduction in insulin use with the addition of BYDUREON.
Clinical Benefit
Insufficient |
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Clinical Added Value
Not applicable |
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Therapeutic use
- |