TRESIBA (insulin degludec), long-acting insulin analogue

ENDOCRINOLOGY - New indication
Opinions on drugs - Posted on Oct 25 2018

Reason for request

Extension of indication

High clinical benefit in the treatment of type 1 diabetes in children (1 – 17 years) but no demonstrated clinical improvement compared to LEVEMIR (insulin detemir).


  • TRESIBA has MA for the treatment of diabetes in adolescents and children from 1 year of age.

  • Its non-inferiority has been demonstrated compared to insulin detemir in terms of HbA1c variation over 26 weeks, in combination with insulin aspart.

  • No benefit in respect of safety, quality of life or convenience of use has been demonstrated.





Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use