At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 348 enrolled
Drug / intervention
insulin detemir +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.
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating insulin detemir, insulin NPH, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 348 participants across 43 sites in 11 countries.
Detailed Summary
This trial is conducted in Europe. The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesBulgaria, Czechia, Denmark, Finland, France, Hungary, North Macedonia, Poland, Russia, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionSep 2008
TodayJul 2026
First PostedFeb 14, 2007
Enrollment StartFeb 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.4 years ago
Interventions
insulin detemirdrug
s.c. injection, once or twice daily.
insulin NPHdrug
s.c. injection, once or twice daily.
insulin aspartdrug
s.c. injection, at main meals.