Study of Metformin Pharmacogenetics in Twins

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Southern Denmark
Sponsor:
Information provided by (Responsible Party):
Tore B. Stage, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01869621
First received: May 28, 2013
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 University of Southern Denmark:

Primary Outcome Measures:
  • Heritability [ Time Frame: After 6 days of metformin treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The effect of SNPs on trough metformin concentration


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Primary Completion Date: June 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869621

Locations
Denmark
Clinical Pharmacology Recruiting
Odense C, Denmark, 5000
Contact: Tore B. Stage, MSc Pharm    +45 6550 3678    tstage@health.sdu.dk   
Principal Investigator: Per Damkier, MD PhD         
Sponsors and Collaborators
University of Southern Denmark
  More Information

No publications provided

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
Study First Received: May 28, 2013
Last Updated: May 31, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The National Committee on Health Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014