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Genetic Variation in the Transporters and Hypoglycemic Agents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Doo-Yeoun Cho, Ajou University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01341795
First Posted: April 26, 2011
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Doo-Yeoun Cho, Ajou University School of Medicine
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin

Further study details as provided by Doo-Yeoun Cho, Ajou University School of Medicine:

Primary Outcome Measures:
  • differences of sitagliptin and metformin trough concentration according to genetic variations of transporters [ Time Frame: After 3 months of sitagliptin and metformin treatment ]

Secondary Outcome Measures:
  • differences of HbA1c change according to genetic variations of transporters [ Time Frame: Baseline and after 3 months of sitagliptin and metformin treatment ]

Biospecimen Retention:   Samples With DNA
Blood

Estimated Enrollment: 100
Study Start Date: July 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly Diagnosed Type 2 Diabetes Patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341795


Locations
Korea, Republic of
Ajou University School of Medicine Recruiting
Suwon, Gyeonggi, Korea, Republic of, 433-721
Contact: Doo-Yeoun Cho, MD    +82-31-219-4271    dooycho@ajou.ac.kr   
Sub-Investigator: Young-Sang Kim, MD         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
  More Information

Responsible Party: Doo-Yeoun Cho, Assitant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01341795     History of Changes
Other Study ID Numbers: GDM01
First Submitted: April 21, 2011
First Posted: April 26, 2011
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Doo-Yeoun Cho, Ajou University School of Medicine:
Newly diagnosed type 2 diabetes patients

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs