At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 enrolled
Drug / intervention
insulin degludec/insulin aspartdrug
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 Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)
In Brief
A Phase 3 clinical trial evaluating insulin degludec/insulin aspart for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 276 participants across 42 sites in 7 countries.
Detailed Summary
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesMalaysia, Mexico, Puerto Rico, South Korea, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedJun 3, 2011
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.1 years ago
Interventions
insulin degludec/insulin aspartdrug
Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.