CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 178 enrolled
Drug / intervention
insulin degludec +3 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/NCT00612040
NCT00612040Phase 2Completed
CompareCT.gov

A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes

Novo Nordisk A/S·interventional·Posted Feb 11, 2008·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating insulin degludec, insulin glargine, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 178 participants across 33 sites in 5 countries.

Detailed Summary

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesAustralia, Germany, Norway, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.4 years ago

Interventions

insulin degludecdrug

Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

insulin degludecdrug

Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

insulin glarginedrug

Treat-to-target dose titration scheme, injection s.c., once daily

insulin aspartdrug

Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily