Diabetes Clinical Trial
Official title:
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: 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 (BOOST™: T1)
This trial is conducted in Europe, Oceania, and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart
(IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes
(main period) followed by the extension period comparing the long-term safety of NN5401 plus
insulin aspart with insulin detemir plus insulin aspart.
The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension
period is registered as NN5401-3645.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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