CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 629 enrolled
Drug / intervention
insulin degludec +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00982228
NCT00982228Phase 3Completed

NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

Novo Nordisk A/S·interventional·Posted Sep 23, 2009·Updated Apr 6, 2017

In Brief

A Phase 3 clinical trial evaluating insulin degludec, insulin glargine, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 629 participants across 91 sites in 6 countries.

Detailed Summary

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Russia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2009
Enrollment StartSep 1, 2009
Primary CompletionNov 8, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.8 years ago

Interventions

insulin degludecdrug

Injected subcutaneously once daily. Dose was individually adjusted.

insulin glarginedrug

Injected subcutaneously once daily. Dose individually adjusted.

insulin aspartdrug

Injected subcutaneously as mealtime insulin. Dose was individually adjusted.