Genetic Basis for Variation in the Renal Elimination of Metformin

NCT00187720 | Completed Phase 4 Results DMC

• 1 other identifier: 787
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

Healthy Control

Outcome Measures

Primary Outcomes (1)

• Renal Clearance of Metformin

  To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.

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

Study Arms (2)

OCT2-variant Group

EXPERIMENTAL

Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin.

Drug: Metformin

OCT2-reference Group

EXPERIMENTAL

Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin.

Drug: Metformin

Interventions

Metformin DRUG

Subjects will be given a single oral dose of 850 mg of metformin

Also known as: GLUCOPHAGE

OCT2-reference Group; OCT2-variant Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
• years old
• Possess a pre-specified genotype for OCT2

You may not qualify if:

• Taking any regular 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 or breastfeeding

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Chen Y, Li S, Brown C, Cheatham S, Castro RA, Leabman MK, Urban TJ, Chen L, Yee SW, Choi JH, Huang Y, Brett CM, Burchard EG, Giacomini KM. Effect of genetic variation in the organic cation transporter 2 on the renal elimination of metformin. Pharmacogenet Genomics. 2009 Jul;19(7):497-504. doi: 10.1097/FPC.0b013e32832cc7e9.

  PMID: 19483665 RESULT

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Recruitment of subjects with interested genotypes was our limitation.

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 Francsico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 10, 2013
• Results First Posted: January 10, 2013

Record last verified: 2012-12

Locations

US (1)