At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 419 enrolled
Drug / intervention
human insulin +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 Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
In Brief
A Phase 4 clinical trial evaluating human insulin and insulin aspart for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 419 participants across 95 sites in 18 countries.
Detailed Summary
This trial was conducted in Europe, Middle East, North America and South America. The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesArgentina, Austria, Bulgaria, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Netherlands, Norway, Poland, Russia, Spain, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2002
Primary CompletionApr 2005
First PostedAug 2006
TodayJul 2026
First PostedAug 17, 2006
Enrollment StartSep 1, 2002
Primary CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.9 years ago
Interventions
human insulindrug
insulin aspartdrug