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A randomised, controlled, open label, multicentre, multinational, treat-to-target trial investigating the efficacy and safety of intensification with addition of bolus insulin aspart in subjects with ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-018974-19

A randomised, controlled, open label, multicentre, multinational, treat-to-target trial investigating the efficacy and safety of intensification with addition of bolus insulin aspart in subjects with type 2 diabetes inadequately controlled on basal insulin with or without oral anti-diabetic drugs: Step-wise addition versus complete basal-bolus therapy

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Extrait

The primary objective of this trial is to confirm efficacy of step-wise addition of bolus insulin in terms of glycaemic control assessed by change in HbA1c. This is done by comparing the difference in change from baseline in HbA1c after 32 weeks of treatment/end of trial between step-wise addition of bolus insulin versus complete basal-bolus therapy using a non-inferiority approach.

Critère d'inclusion

  • Type 2 Diabetes

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