At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 146 enrolled
Drug / intervention
insulin detemir +1 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.
A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin
In Brief
A Phase 3 clinical trial evaluating insulin detemir and insulin aspart for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 146 participants across 32 sites in 11 countries.
Detailed Summary
This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
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
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedFeb 25, 2008
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.4 years ago
Interventions
insulin detemirdrug
Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
insulin aspartdrug
Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.