CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 470 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.

Search/NCT00474045
NCT00474045Phase 3Completed
CompareCT.gov

A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Women With Type 1 Diabetes

Novo Nordisk A/S·interventional·Posted May 16, 2007·Updated Mar 10, 2017

In Brief

A Phase 3 clinical trial evaluating insulin detemir, NPH insulin, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 470 participants across 98 sites in 17 countries.

Detailed Summary

This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesArgentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, Finland, France, Ireland, Israel, Norway, Poland, Russia, South Africa, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.1 years ago

Interventions

insulin detemirdrug

Treat-to-target, dose titration, s.c. (under the skin) injection

NPH insulindrug

Treat-to-target, dose titration, s.c. (under the skin) injection

insulin aspartdrug

Treat-to-target, dose titration, s.c. (under the skin) injection