CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 362 enrolled
Drug / intervention
insulin degludec/insulin aspart +3 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/NCT01835431
NCT01835431Phase 3Completed
CompareCT.gov

A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted Apr 19, 2013·Updated Jun 11, 2019

In Brief

A Phase 3 clinical trial evaluating insulin degludec/insulin aspart, insulin aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 362 participants across 73 sites in 15 countries.

Detailed Summary

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesBelgium, Brazil, Canada, Croatia, Czechia, India, Israel, North Macedonia, Poland, Russia, Serbia, Slovenia, South Africa, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2013
Enrollment StartOct 17, 2013
Primary CompletionNov 7, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.2 years ago

Interventions

insulin degludec/insulin aspartdrug

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

insulin aspartdrug

Administered s.c. with the remaining meals. Dose individually adjusted.

insulin detemirdrug

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

insulin aspartdrug

Administered s.c. at meal-times. Dose individually adjusted.