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EUCREAS/ICANDRA (vildagliptin/metformin), antidiabetics
DIABETOLOGY - New indication
Opinions on drugs -
Posted on
Feb 24 2015
Reason for request
Extension of indication
No clinical added value demonstrated for vildagliptin combined with metformin and a sulfonylurea by comparison with triple therapy in the management of type 2 diabetes
- GALVUS/JALRA has Marketing Authorisation in combination with metformin and a sulfonylurea when dual therapy with these medicines, diet and exercise do not provide adequate glycaemic control.
- The fixed-dose combination EUCREAS/ICANDRA is indicated in combination with a sulfonylurea (i.e. triple therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulfonylurea.
- 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
| Moderate |
the actual benefit of EUCREAS/ICANDRA is moderate in triple therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when a stable dose of insulin and metformin alone do not provide adequate glycaemic control. |
Clinical Added Value
| no clinical added value |
As there are no direct comparisons with validated and available triple therapies, and as there is no clinical study with the fixed-dose combination, the Transparency Committee considers that EUCREAS/ICANDRA does not provide any improvement in actual benefit (level V, non-existent) in the treatment of patients with type 2 diabetes in triple therapy, in combination with insulin. |
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