CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 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/NCT01513473
NCT01513473Phase 3Completed
CompareCT.gov

A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)

Novo Nordisk A/S·interventional·Posted Jan 20, 2012·Updated Jun 13, 2019

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 350 participants across 81 sites in 12 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesBulgaria, Finland, France, Germany, Italy, Japan, Netherlands, North Macedonia, Russia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2012
Enrollment StartJan 16, 2012
Primary CompletionJul 30, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.5 years ago

Interventions

insulin degludecdrug

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

insulin detemirdrug

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

insulin aspartdrug

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.