Study of Metformin Pharmacogenetics in Twins

Type 2 Diabetes Clinical Trial

Official title:

The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869621
• Other study ID #: AKF-383
• Secondary ID: 2012-005179-15
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2013
• Last updated: December 2, 2014
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Metformin
6 days treatment with metformin to steady-state

Locations

Country	Name	City	State
Denmark	Clinical Pharmacology	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heritability	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.	After 6 days of metformin treatment	No
Secondary	Single nucleotide polymorphisms (SNPs)	The effect of SNPs on trough metformin concentration	After 6 days treatment with metformin	No