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NCT01341795 Clinical Trial

Genetic Variation in the Transporters and Hypoglycemic Agents

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01341795
Other study ID # GDM01
Secondary ID
Status Recruiting
Phase N/A
First received April 21, 2011
Last updated March 25, 2014
Start date July 2011

Study information
Verified date March 2014
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Ajou University School of Medicine Suwon Gyeonggi

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary differences of sitagliptin and metformin trough concentration according to genetic variations of transporters After 3 months of sitagliptin and metformin treatment No
Secondary differences of HbA1c change according to genetic variations of transporters Baseline and after 3 months of sitagliptin and metformin treatment No
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