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

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ClinicalTrials.gov Identifier: NCT01400191
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : June 26, 2015
Sponsor:
Collaborator:
Region of Southern Denmark
Information provided by (Responsible Party):
Mette Marie Hougaard Christensen, 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.

Condition or disease Intervention/treatment Phase
Pharmacogenetics of Metformin Drug: Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Endogenous glucose production [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400191


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Marie Hougaard Christensen, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01400191     History of Changes
Other Study ID Numbers: AKF 379
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

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

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