Femme et Homme
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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 glargine, both in combination with insulin aspart, after 104 weeks of treatment (52-weeks treatment in NN1250-3583 plus 52-week treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events (AE) • Hypoglycaemic episodes • Clinical evaluation • Central laboratory assessments • Body weight • Insulin dose The data from trial NN1250-3583 and this extension trial will be combined and analysed as one (2-year) trial using the baseline values from trial NN1250-3583.
Critère d'inclusion
- Type 1 Diabetes