At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 enrolled
Drug / intervention
Metformindrug
Likely dose
Metformin 1000 mg orally on Day 1, then 850 mg orally on Day 2AI-extracted
Key inclusion· 3
- ✓Previous participation in the SOPHIE study (Study Of Pharmacogenetics In Ethnically Diverse Populations)
- ✓Age 18-40 years
- ✓Possess a specific OCT1 genotype
Key exclusion· 5
- ✕Taking any medications other than vitamins
- ✕Anemia with hemoglobin < 12 g/dL
- ✕Liver enzyme elevation greater than double the upper normal limit
- ✕Elevated creatinine: males ≥ 1.5 mg/dL or females ≥ 1.4 mg/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects
In Brief
A Phase 4 clinical trial evaluating Metformin for Other Conditions That May Be A Focus of Clinical Attention. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Specific Objectives: * To determine if individuals who carry a decreased or non-functional variant of OCT1 exhibit differences in the pharmacokinetics of metformin in comparison to individuals who carry the common allele. * To determine if individuals who carry the decreased or non-functional variants exhibit differences in the response to metformin in comparison to individuals who carry the common allele.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2003
First PostedSep 2005
Primary CompletionMar 2008
TodayJul 2026
First PostedSep 16, 2005
Enrollment StartJul 1, 2003
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago
Interventions
Metformindrug
2 doses of Metformin Day 1 1000mg, Day 2 850 mg