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

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ClinicalTrials.gov Identifier: NCT00187681
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects
Study Start Date : July 2003
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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.

  2. Glucose Lowering Response to Metformin [ Time Frame: 0 to 180 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187681     History of Changes
Other Study ID Numbers: 865
First Posted: September 16, 2005    Key Record Dates
Results First Posted: January 8, 2013
Last Update Posted: January 8, 2013
Last Verified: December 2012

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

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