Study of Metformin Pharmacogenetics in Twins

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin

• Registration Number: NCT01869621
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	6 days treatment with metformin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Single nucleotide polymorphisms (SNPs)	After 6 days treatment with metformin	The effect of SNPs on trough metformin concentration

Trial Locations

Locations (1)

Clinical Pharmacology; 🇩🇰 Odense C, Denmark