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A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers

This study has been completed.
Sponsor:
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01237522
First received: November 8, 2010
Last updated: December 28, 2010
Last verified: June 2010
History of Changes
  Purpose

The aim of the study is to evaluate the pharmacokinetics of metformin in healthy Caucasians volunteers with and without the polymorphism A270S in OCT2,thus the study hypothesis is that renal clearance of metformin is affected in Caucasian with the known single nucleotide polymorphisms A270S in OCT2.


Condition Intervention Phase
Metformin
Organic Cation Transporter 2
Polymorphism,Single Nucleotide
 Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pharmacokinetic Evaluation of Metformin in Relation to the Polymorphism A270S in Healthy Caucasian Volunteers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Renal clearance of metformin [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Homozygote for the A270S wildetype Drug: Metformin
A single dose study with one tablet of metformin 500 mg, time frame 24 hours
Other Name: Orabet
Active Comparator: Homo- or heterozygote for A270S minor alleles Drug: Metformin
A single dose study with one tablet of metformin 500 mg, time frame 24 hours
Other Name: Orabet

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written consent
  • rs316019 genotyped
  • Age 18-65 years old

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237522

Locations
Denmark
Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
Study Chair: Kim Broesen, Professor University of Southern Denmark
  More Information

No publications provided

Responsible Party: Mette Marie Hougaard Christensen, Institute of Public Health, Clinical Pharmacology, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01237522     History of Changes
Other Study ID Numbers: AKF- 377
Study First Received: November 8, 2010
Last Updated: December 28, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Diabetes Mellitus, Type 2
Metabolic Clearance Rate
Pharmacokinetics
Pharmacogenetics

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

ClinicalTrials.gov processed this record on May 23, 2013