Genetic Variation in the Transporters and Hypoglycemic Agents
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|ClinicalTrials.gov Identifier: NCT01341795|
Recruitment Status : Unknown
Verified March 2014 by Doo-Yeoun Cho, Ajou University School of Medicine.
Recruitment status was: Recruiting
First Posted : April 26, 2011
Last Update Posted : March 26, 2014
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 or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin|
|Study Start Date :||July 2011|
- differences of sitagliptin and metformin trough concentration according to genetic variations of transporters [ Time Frame: After 3 months of sitagliptin and metformin treatment ]
- differences of HbA1c change according to genetic variations of transporters [ Time Frame: Baseline and after 3 months of sitagliptin and metformin treatment ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341795
|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 firstname.lastname@example.org|
|Sub-Investigator: Young-Sang Kim, MD|
|Principal Investigator:||Doo-Yeoun Cho, MD||Ajou University School of Medicine|