NCT00187681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

January 8, 2013

Completed
Last Updated

January 8, 2013

Status Verified

December 1, 2012

Enrollment Period

4.7 years

First QC Date

September 13, 2005

Results QC Date

May 20, 2011

Last Update Submit

December 6, 2012

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

Healthy controls

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve (AUC) of Blood Concentration-time of Metformin

    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.

    0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours

  • Glucose Lowering Response to Metformin

    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.

    0 to 180 minutes

Study Arms (2)

OCT1-variant Group

EXPERIMENTAL

Subjects with OCT1-variant alleles will be dosed with 2 doses of Metformin

Drug: Metformin

OCT1-reference Group

EXPERIMENTAL

Subjects with OCT1-reference alleles will be dosed with 2 doses of Metformin

Drug: Metformin

Interventions

MetforminDRUG

2 doses of Metformin Day 1 1000mg, Day 2 850 mg

Also known as: Dimethylguanylguanidine, Glucophage
OCT1-reference GroupOCT1-variant Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francsico, California, 94143, United States

Location

Related Publications (2)

  • Shu Y, Sheardown SA, Brown C, Owen RP, Zhang S, Castro RA, Ianculescu AG, Yue L, Lo JC, Burchard EG, Brett CM, Giacomini KM. Effect of genetic variation in the organic cation transporter 1 (OCT1) on metformin action. J Clin Invest. 2007 May;117(5):1422-31. doi: 10.1172/JCI30558.

    PMID: 17476361RESULT

  • Shu Y, Brown C, Castro RA, Shi RJ, Lin ET, Owen RP, Sheardown SA, Yue L, Burchard EG, Brett CM, Giacomini KM. Effect of genetic variation in the organic cation transporter 1, OCT1, on metformin pharmacokinetics. Clin Pharmacol Ther. 2008 Feb;83(2):273-80. doi: 10.1038/sj.clpt.6100275. Epub 2007 Jul 4.

    PMID: 17609683RESULT

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Kathy Giacomini, Ph.D
Organization
UCSF
Kathy.Giacomini@ucsf.edu
4154761936

Study Officials

  • Kathleen M Giacomini, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

July 1, 2003

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 8, 2013

Results First Posted

January 8, 2013

Record last verified: 2012-12

Locations

US(1)