Phase 4 N=20

Organic Cation Transporter 1 (OCT1), on Response to Metformin in Healthy Subjects

Other Conditions That May Be A Focus of Clinical Attention

Bottom Line

View on ClinicalTrials.gov: NCT00187681 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcome: Primary: Area Under the Curve (AUC) of Blood Concentration-time of Metformin — 9,200; 7,700 hour * µg/L

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: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC) of Blood Concentration-time of Metformin	9,200; 7,700	—
PRIMARY Glucose Lowering Response to Metformin	18,200; 21,300	—

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.

Eligibility Criteria

Inclusion Criteria

Previous participation in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
Between the ages of 18 and 40.
Possess a specific OCT1 genotype.

Exclusion Criteria

Taking any 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 at time of study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00187681). 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.