Phase 4
Completed N=23
Genetic Basis for Variation in the Renal Elimination of Metformin
Other Conditions That May Be A Focus of Clinical Attention
Source: ClinicalTrials.gov NCT00187720 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Renal Clearance of Metformin — 614; 441 mL/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Clearance of Metformin |
614; 441 | — |
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. Informational only — not medical advice.