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Opinions on drugs - Posted on Sep 15 2014

Reason for request

Re-assessment at the Committee's initiative following the opinion of 25 May 2011 and Renewal of inclusion

Clinical Benefit


Remains substantial in type 1 and type 2 diabetes.

Clinical Added Value

no clinical added value

Given, on the one hand :
- the glycaemic control obtained with LANTUS (insulin glargine) compared with that observed with NPH insulin and in sulin detemir (LEVEMIR),

- the absence of a difference between insulin glargine, insulin detemir and NPH insulin in terms of the occurrence of severe hypoglycaemia and between insulin glargine and insulin detemir in terms of overall and nocturnal hypoglycaemia,

- the opinion of experts who do not recognise any benefit in their daily practice of using LANTUS compared with another long acting insulin analogue,

And, on the other hand,
- current recommendations which no longer favour treatment intensification for type 2 diabetes, which reduces the risk of hypoglycaemia,

the Transparency Committee cannot confirm the previously recognised benefit of LANTUS (minor IAB in terms of safety) in type 1 and type 2 diabetes.

Thus, the Committee considers that LANTUS (insulin glargine) does not provide an improvement in actual benefit (levelV, non-existent) in the management of adult or adolescent patients and children aged 2 and above with type 1 or type 2 diabetes.