A trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus

Mise à jour : Il y a 4 ans
Référence : U1111-1122-4758

Femme et Homme

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Extrait

To confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HBA1c after 26 weeks of treatment. This is done by comparing the difference in change in HbA1c between insulin degludec + insulin aspart and insulin detemir + insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.


Critère d'inclusion

  • Diabetes Mellitus, Type 1