Phase 4
N=23
Genetic Basis for Variation in the Renal Elimination of Metformin
Other Conditions That May Be A Focus of Clinical Attention
Bottom Line
View on ClinicalTrials.gov: NCT00187720 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Renal Clearance of Metformin — 614; 441 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metformin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Clearance of Metformin |
614; 441 | — |
Summary
The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.
Eligibility Criteria
Inclusion Criteria
- Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
- 18-40 years old
- Possess a pre-specified genotype for OCT2
Exclusion Criteria
- Taking any regular medications other than vitamins.
- Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00187720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.