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An extension trial comparing safety and efficacy of NN5401 plus meal-time insulin aspart for the remaining meals with insulin detemir plus meal-time insulin aspart in type 1 diabetes

Update Il y a 4 ans
Reference: EUCTR2009-013412-13

Woman and Man

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Extract

The primary objective is to investigate the long-term safety and tolerability of SIAC. This is done by comparing SIAC to insulin detemir after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 plus 26 weeks of treatment in this extension trial) in terms of the following safety assessments from which endpoints will be calculated: • Adverse events • Hypoglycaemic episodes • Clinical evaluations • Central laboratory assessments including lipid profiles and insulin antibodies • Body weight • Insulin dose

Inclusion criteria

  • Type 1 Diabetes

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