The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 4

Conditions: Pharmacogenetics of Metformin

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01400191

AKF 379

Details and patient eligibility

About

The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Written consent
• Genotyped in OCT1 for (M420del and R61C)

Exclusion criteria

• Daily medication
• Alcohol abuse
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 3 patient groups

Homozygote wildtype OCT1

Active Comparator group

Treatment:

Drug: Metformin

Heterozygote OCT1

Active Comparator group

Treatment:

Drug: Metformin

Homozygote OCT1 variant

Active Comparator group

Treatment:

Drug: Metformin