Genetic Variation in the Transporters and Hypoglycemic Agents

NCT ID: NCT01341795

Last Updated: 2014-03-26

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Brief Summary

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Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available.

In clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications.

Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Newly Diagnosed Type 2 Diabetes Patients
* 20-80 years old
* Taking sitagliptin and metformin for more than 3 months

Exclusion Criteria

* Taking other oral hypoglycemic agents
* Taking medications can induce or inhibit transporters
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Doo-Yeoun Cho

Assitant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doo-Yeoun Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Doo-Yeoun Cho, MD

Role: primary

+82-31-219-4271

Other Identifiers

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GDM01

Identifier Type: -

Identifier Source: org_study_id

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