At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 325 enrolled
Drug / intervention
Human Regular U-500 Insulindrug
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.
Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial
In Brief
A Phase 4 clinical trial evaluating Human Regular U-500 Insulin for Diabetes Mellitus, Type 2. Completed, enrolled 325 participants across 39 sites in 2 countries.
Detailed Summary
The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago
Interventions
Human Regular U-500 Insulindrug