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Genetic Variation in the Transporters and Hypoglycemic Agents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Ajou University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01341795
First received: April 21, 2011
Last updated: August 10, 2011
Last verified: April 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 100
Study Start Date: July 2011
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Doo-Yeoun Cho/Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01341795     History of Changes
Other Study ID Numbers: GDM01
Study First Received: April 21, 2011
Last Updated: August 10, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
Newly diagnosed type 2 diabetes patients

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

ClinicalTrials.gov processed this record on May 23, 2013