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Study of Metformin Pharmacogenetics in Twins

This study has been completed.
Information provided by (Responsible Party):
Tore B. Stage, University of Southern Denmark Identifier:
First received: May 28, 2013
Last updated: December 2, 2014
Last verified: December 2014
The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.

Condition Intervention Phase
Type 2 Diabetes Drug: Metformin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins

Resource links provided by NLM:

Further study details as provided by Tore B. Stage, University of Southern Denmark:

Primary Outcome Measures:
  • Heritability [ Time Frame: After 6 days of metformin treatment ]
    The trough concentrations of metformin in twin pairs will be used to determine the effect of heritability on metformin trough concentrations. This will give insight to the weight that genetic factors have on metformin pharmacokinetics at steady-state.

Secondary Outcome Measures:
  • Single nucleotide polymorphisms (SNPs) [ Time Frame: After 6 days treatment with metformin ]
    The effect of SNPs on trough metformin concentration

Enrollment: 34
Study Start Date: April 2013
Study Completion Date: October 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
6 days treatment with metformin
Drug: Metformin
6 days treatment with metformin to steady-state


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-40 years
  • Both twins has to be included
  • Dizygotic twin pairs has to be same sex
  • Informed consent given
  • Healthy condition

Exclusion Criteria:

  • Chronical/daily alcohol abuse
  • Hypersensitivity to metformin
  • Ingestion of drugs containing topiramate or x-ray contrast fluids
  • For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives
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Please refer to this study by its identifier: NCT01869621

Clinical Pharmacology
Odense C, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
  More Information

Responsible Party: Tore B. Stage, MSc Pharm, University of Southern Denmark Identifier: NCT01869621     History of Changes
Other Study ID Numbers: AKF-383
2012-005179-15 ( EudraCT Number )
Study First Received: May 28, 2013
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017