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

This study has been completed.
Sponsor:
Collaborator:
Region Southern Denmark
Information provided by (Responsible Party):
Mette Marie Hougaard Christensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01400191
First received: July 21, 2011
Last updated: June 25, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Pharmacogenetics of Metformin
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Endogenous glucose production [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Homozygote wildtype OCT1 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.
Active Comparator: Heterozygote OCT1 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.
Active Comparator: Homozygote OCT1 variant 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400191

Locations
Denmark
Clinical pharmacology, Institute og public health, University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Investigators
Principal Investigator: Mette Marie H Christensen, MD Department of Public Health, Clinical Pharmacology, University of Southen Denmark
  More Information

No publications provided

Responsible Party: Mette Marie Hougaard Christensen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01400191     History of Changes
Other Study ID Numbers: AKF 379
Study First Received: July 21, 2011
Last Updated: June 25, 2015
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Metformin
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Gluconeogenesis
Pharmacodynamics
Pharmacogenetics

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 31, 2015