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

Phase 4

Completed

• Conditions: Pharmacogenetics of Metformin
• Interventions: Drug: Metformin

• Registration Number: NCT01400191
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

Exclusion Criteria

• Daily medication
• Alcohol abuse
• Pregnancy
• Breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homozygote OCT1 variant	Metformin	-
Homozygote wildtype OCT1	Metformin	-
Heterozygote OCT1	Metformin	-

Primary Outcome Measures

Name	Time	Method
Endogenous glucose production	48 hours

Trial Locations

Locations (1)

Clinical pharmacology, Institute og public health, University of Southern Denmark; 🇩🇰 Odense, Denmark