At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 834 enrolled
Drug / intervention
Faster-acting insulin aspart +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.
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Faster-acting insulin aspart, insulin aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 834 participants across 155 sites in 18 countries.
Detailed Summary
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesBulgaria, Czechia, Estonia, Finland, Germany, India, Israel, Italy, Japan, Latvia, Lithuania, Poland, Puerto Rico, Russia, Serbia, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMay 2016
Primary CompletionFeb 2018
Study CompletionMar 2018
TodayJul 2026
First PostedFeb 2, 2016
Enrollment StartMay 4, 2016
Primary CompletionFeb 5, 2018
Study CompletionMar 3, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.4 years ago
Interventions
Faster-acting insulin aspartdrug
For subcutaneous (s.c., under the skin) injection once daily.
insulin aspartdrug
For subcutaneous (s.c., under the skin) injection once daily.
insulin degludecdrug
For subcutaneous (s.c., under the skin) injection once daily.