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LEVEMIR (insulin detemir), long-acting human insulin analogue

DIABETOLOGY - New indication
Opinions on drugs - Posted on Mar 03 2017

Reason for request

Extension of indication

No actual benefit demonstrated relative to TRESIBA in the management of type 1 diabetes in children aged 1 to 2 years.

  •   LEVEMIR has Marketing Authorisation in type 1 diabetes in children aged 1 year.
  • The available clinical efficacy data in children between age 1 and 2 years are limited to a non-inferiority study versus insulin degludec conducted on 350 children with type 1 diabetes aged between 1 and 17 years, of which only 4 were aged 1 to 2 years.



Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


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