Genetic Variation in the Transporters and Hypoglycemic Agents
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT01341795
- Lead Sponsor
- Ajou University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Newly Diagnosed Type 2 Diabetes Patients
- 20-80 years old
- Taking sitagliptin and metformin for more than 3 months
- Taking other oral hypoglycemic agents
- Taking medications can induce or inhibit transporters
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method differences of sitagliptin and metformin trough concentration according to genetic variations of transporters After 3 months of sitagliptin and metformin treatment
- Secondary Outcome Measures
Name Time Method differences of HbA1c change according to genetic variations of transporters Baseline and after 3 months of sitagliptin and metformin treatment
Trial Locations
- Locations (1)
Ajou University School of Medicine
🇰🇷Suwon, Gyeonggi, Korea, Republic of