The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 26, 2015
June 1, 2015
11 months
July 21, 2011
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endogenous glucose production
48 hours
Study Arms (3)
Homozygote wildtype OCT1
ACTIVE COMPARATORHeterozygote OCT1
ACTIVE COMPARATORHomozygote OCT1 variant
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- Healthy volunteers
- Written consent
- Genotyped in OCT1 for (M420del and R61C)
You may not qualify if:
- Daily medication
- Alcohol abuse
- Pregnancy
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Region of Southern Denmarkcollaborator
Study Sites (1)
Clinical pharmacology, Institute og public health, University of Southern Denmark
Odense, 5000, Denmark
Related Publications (1)
Christensen MM, Hojlund K, Hother-Nielsen O, Stage TB, Damkier P, Beck-Nielsen H, Brosen K. Endogenous glucose production increases in response to metformin treatment in the glycogen-depleted state in humans: a randomised trial. Diabetologia. 2015 Nov;58(11):2494-502. doi: 10.1007/s00125-015-3733-2. Epub 2015 Aug 14.
PMID: 26271344DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mette Marie H Christensen, MD
Department of Public Health, Clinical Pharmacology, University of Southen Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 22, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 26, 2015
Record last verified: 2015-06