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

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 4

Conditions: Organic Cation Transporter 2; Metformin; Polymorphism,Single Nucleotide

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01237522

AKF- 377

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Daily medication
• Alcohol abuse
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Homozygote for the A270S wildetype

Active Comparator group

Treatment:

Drug: Metformin

Homo- or heterozygote for A270S minor alleles

Active Comparator group

Treatment:

Drug: Metformin