Skip to main content
Clinical Trials/NCT01341795
NCT01341795UnknownNot Applicable

Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin

Ajou University School of Medicine1 site in 1 country100 target enrollmentStarted: July 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
differences of sitagliptin and metformin trough concentration according to genetic variations of transporters

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Time Perspective
Retrospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

differences of sitagliptin and metformin trough concentration according to genetic variations of transporters

Time Frame: After 3 months of sitagliptin and metformin treatment

Secondary Outcomes

  • differences of HbA1c change according to genetic variations of transporters(Baseline and after 3 months of sitagliptin and metformin treatment)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Doo-Yeoun Cho

Assitant Professor

Ajou University School of Medicine

Study Sites (1)

Loading locations...

Similar Trials