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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187681
First received: September 13, 2005
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention Phase
Other Conditions That May Be A Focus of Clinical Attention
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of Blood Concentration-time of Metformin [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours ] [ Designated as safety issue: No ]
    To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.

  • Glucose Lowering Response to Metformin [ Time Frame: 0 to 180 minutes ] [ Designated as safety issue: No ]
    To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.


Enrollment: 20
Study Start Date: July 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCT1-variant Group
Subjects with OCT1-variant alleles will be dosed with 2 doses of Metformin
Drug: Metformin
2 doses of Metformin Day 1 1000mg, Day 2 850 mg
Other Names:
  • Dimethylguanylguanidine
  • Glucophage
Experimental: OCT1-reference Group
Subjects with OCT1-reference alleles will be dosed with 2 doses of Metformin
Drug: Metformin
2 doses of Metformin Day 1 1000mg, Day 2 850 mg
Other Names:
  • Dimethylguanylguanidine
  • Glucophage

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187681

Locations
United States, California
San Francisco General Hospital
San Francsico, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen M Giacomini, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187681     History of Changes
Other Study ID Numbers: 865
Study First Received: September 13, 2005
Results First Received: May 20, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Healthy controls

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014