TRESIBA (insulin degludec), long-acting insulin analogue
Reason for request
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.
Improvement in actual benefit