CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 37 enrolled
Drug / intervention
Metformindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01400191
NCT01400191Phase 4Completed
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The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

University of Southern Denmark·interventional·Posted Jul 22, 2011·Updated Jun 26, 2015

In Brief

A Phase 4 clinical trial evaluating Metformin for Pharmacogenetics of Metformin. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacogenetics of Metformin
CountriesDenmark
CollaboratorsRegion of Southern Denmark

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2011
Enrollment StartJan 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.9 years ago

Interventions

Metformindrug

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.