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Study of Metformin Pharmacogenetics in Twins

NCT ID: NCT01869621

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin

6 days treatment with metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

6 days treatment with metformin to steady-state

Interventions

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Metformin

6 days treatment with metformin to steady-state

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Tore B. Stage

MSc Pharm

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Pharmacology

Odense C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2012-005179-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AKF-383

Identifier Type: -

Identifier Source: org_study_id