NCT01237522

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 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

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 29, 2010

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

November 8, 2010

Last Update Submit

December 28, 2010

Conditions

MetforminOrganic Cation Transporter 2Polymorphism,Single Nucleotide

Keywords

Diabetes Mellitus, Type 2Metabolic Clearance RatePharmacokineticsPharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • Renal clearance of metformin

    24 Hours

Study Arms (2)

Homozygote for the A270S wildetype

ACTIVE COMPARATOR
Drug: Metformin

Homo- or heterozygote for A270S minor alleles

ACTIVE COMPARATOR
Drug: Metformin

Interventions

MetforminDRUG

A single dose study with one tablet of metformin 500 mg, time frame 24 hours

Also known as: Orabet
Homo- or heterozygote for A270S minor allelesHomozygote for the A270S wildetype

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Public Health, Clinical Pharmacology, University of Southern Denmark

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminTolbutamide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Kim Broesen, Professor

    University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 29, 2010

Record last verified: 2010-06

Locations

DK(1)