CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Metformindrug
Likely dose
Metformin 850 mg orally, single doseAI-extracted
Key inclusion· 3
  • ✓Prior participation in the SOPHIE study
  • ✓Age 18-40 years
  • ✓Pre-specified OCT2 genotype required
Key exclusion· 5
  • ✕No regular medications except vitamins
  • ✕No anemia (hemoglobin <12 g/dL excluded)
  • ✕Liver enzymes must not exceed double the normal upper limit
  • ✕Elevated creatinine: males ≥1.5 mg/dL, females ≥1.4 mg/dL excluded

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

Search/NCT00187720
NCT00187720Phase 4Completed
CompareCT.gov

Genetic Basis for Variation in the Renal Elimination of Metformin

University of California, San Francisco·interventional·Posted Sep 16, 2005·Updated Jan 10, 2013

In Brief

A Phase 4 clinical trial evaluating Metformin for Other Conditions That May Be A Focus of Clinical Attention. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOther Conditions That May Be A Focus of Clinical Attention
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMay 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

Metformindrug

Subjects will be given a single oral dose of 850 mg of metformin