At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 401 enrolled
Drug / intervention
insulin aspart +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.
A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin With or Without Oral Anti-diabetic Drugs: Step-wise Addition Versus Complete Basal-bolus Therapy
In Brief
A Phase 4 clinical trial evaluating insulin aspart and insulin detemir for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 401 participants across 67 sites in 7 countries.
Detailed Summary
This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Brazil, Canada, France, North Macedonia, Slovenia, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartOct 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedJul 20, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.0 years ago
Interventions
insulin aspartdrug
Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted.
insulin aspartdrug
Insulin aspart added before each main meal. Doses individually adjusted.
insulin detemirdrug
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.