Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin
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
Doo-Yeoun Cho
Assitant Professor
Ajou University School of Medicine