CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 296 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/NCT00537303
NCT00537303Phase 4Completed
CompareCT.gov

Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Oct 1, 2007·Updated Mar 10, 2017

In Brief

A Phase 4 clinical trial evaluating insulin detemir and insulin aspart for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 296 participants across 69 sites in 12 countries.

Detailed Summary

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesDenmark, Finland, France, Netherlands, Norway, Russia, Serbia and Montenegro, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.8 years ago

Interventions

insulin detemirdrug

Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)

insulin aspartdrug

Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)

insulin aspartdrug

Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)