At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating insulin degludec/insulin aspart, insulin detemir, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 548 participants across 81 sites in 10 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.