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

NCT ID: NCT01237522

Last Updated: 2010-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metformin Organic Cation Transporter 2 Polymorphism,Single Nucleotide

Keywords

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Diabetes Mellitus, Type 2 Metabolic Clearance Rate Pharmacokinetics Pharmacogenetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Homozygote for the A270S wildetype

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Homo- or heterozygote for A270S minor alleles

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

Other Intervention Names

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Orabet

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Kim Broesen, Professor

Role: STUDY_CHAIR

University of Southern Denmark

Locations

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

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AKF- 377

Identifier Type: -

Identifier Source: org_study_id