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Study of Metformin Pharmacogenetics in Twins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869621
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Metformin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Study Start Date : April 2013
Primary Completion Date : March 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Metformin
6 days treatment with metformin
Drug: Metformin
6 days treatment with metformin to steady-state


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Single nucleotide polymorphisms (SNPs) [ Time Frame: After 6 days treatment with metformin ]
    The effect of SNPs on trough metformin concentration


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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): NCT01869621


Locations
Denmark
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
ClinicalTrials.gov Identifier: NCT01869621     History of Changes
Other Study ID Numbers: AKF-383
2012-005179-15 ( EudraCT Number )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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