At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 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 Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, Both With Insulin Aspart at Mealtimes
In Brief
A Phase 4 clinical trial evaluating insulin detemir and insulin NPH for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesSpain
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartApr 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedNov 21, 2008
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago
Interventions
insulin detemirdrug
Insulin detemir once daily plus insulin aspart at mealtime
insulin NPHdrug
Insulin NPH once daily plus insulin aspart at mealtime