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A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005769-71

A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes

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Extrait

To confirm efficacy of SIAC once daily (OD) + meal-time insulin aspart for the remaining meals 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 from baseline in HbA1c after 26 weeks of treatment between SIAC OD + meal-time insulin aspart for the remaining meals and insulin detemir + meal-time 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

  • Type 1 Diabetes

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