Phase 4 Completed N=20

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

Other Conditions That May Be A Focus of Clinical Attention

Source: ClinicalTrials.gov NCT00187681 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

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

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.

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	—

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. Informational only — not medical advice.