At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
acipimox +1 moredrug
Likely dose
Acipimox 250 mg orally every 6 hours for 7 daysAI-extracted
Key inclusion· 4
- ✓Type 2 diabetes mellitus as defined by the National Diabetes Data Group
- ✓Normal cardiovascular exam
- ✓Non-smoker for at least 1 year prior to entry
- ✓Fasting glucose <110 mg/dL
Key exclusion· 8
- ✕Untreated hypertension (>140/90 mmHg)
- ✕Untreated hypercholesterolemia (LDL >75th percentile for age)
- ✕Cigarette smoking within 1 year
- ✕Neuropathy requiring medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Impact of Free Fatty Acid Reduction on Vascular Function and Skeletal Muscle Glucose Utilization in Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating acipimox and placebo for Type 2 Diabetes Mellitus. Completed, enrolled 40 participants across 1 site.
Detailed Summary
This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2005
First PostedSep 2005
Primary CompletionDec 2011
Study CompletionMar 2013
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago
Interventions
acipimoxdrug
subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit
placebodrug
matching placebo