An extension trial to NN1250-3585 investigating safety and efficacy of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus in a basal/bolus treatment regimen

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-015721-36

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Extrait

The primary objective is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 to insulin detemir, both in combination with insulin aspart after 52 weeks of treatment (26 weeks of treatment in trial NN1250-3585 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events (AEs) • Hypoglycaemic episodes • Clinical evaluations • Laboratory assessments • Insulin dose • Body weight


Critère d'inclusion

  • Type 1 diabetes mellitus