Study of Metformin Pharmacogenetics in Twins

Sponsor

University of Southern Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01869621

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

34 participants

Allocation:

N/A

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 :

Apr 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

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

Heritability [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) [After 6 days treatment with metformin]
The effect of SNPs on trough metformin concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology	Odense C		Denmark	5000

Sponsors and Collaborators

University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tore B. Stage, MSc Pharm, University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT01869621

Other Study ID Numbers:

AKF-383
2012-005179-15

First Posted:

Jun 5, 2013

Last Update Posted:

Dec 3, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Metformin

Study Results

No Results Posted as of Dec 3, 2014