Genetic Variation in the Transporters and Hypoglycemic Agents
Recruitment status was: Recruiting
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.
Type 2 Diabetes
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin|
- 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 ]
- 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
|Study Start Date:||July 2011|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341795
|Korea, Republic of|
|Ajou University School of Medicine|
|Suwon, Gyeonggi, Korea, Republic of, 433-721|
|Principal Investigator:||Doo-Yeoun Cho, MD||Ajou University School of Medicine|