At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)
In Brief
A Phase 3 clinical trial evaluating insulin degludec, insulin detemir, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 456 participants across 69 sites in 8 countries.
Detailed Summary
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart. The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
Study Details
Timeline
Interventions
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.