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).
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TRESIBA has MA for the treatment of diabetes in adolescents and children from 1 year of age.
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Its non-inferiority has been demonstrated compared to insulin detemir in terms of HbA1c variation over 26 weeks, in combination with insulin aspart.
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No benefit in respect of safety, quality of life or convenience of use has been demonstrated.
Clinical Benefit
| Substantial |
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Clinical Added Value
| no clinical added value |
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Therapeutic use
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