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

Pharmacogenetics of Metformin Clinical Trial

Official title:

The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400191
• Other study ID #: AKF 379
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2011
• Last updated: June 25, 2015
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Written consent

• Genotyped in OCT1 for (M420del and R61C)

Exclusion Criteria:

• Daily medication

• Alcohol abuse

• Pregnancy

• Breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pharmacogenetics of Metformin

Intervention

Drug:
• Metformin
The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.

Locations

Country	Name	City	State
Denmark	Clinical pharmacology, Institute og public health, University of Southern Denmark	Odense

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous glucose production		48 hours	No