Genetic Variation in the Transporters and Hypoglycemic Agents

NCT01341795 | Unknown

• 1 other identifier: GDM01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Newly diagnosed type 2 diabetes patients

Outcome Measures

Primary Outcomes (1)

• differences of sitagliptin and metformin trough concentration according to genetic variations of transporters

  After 3 months of sitagliptin and metformin treatment

Secondary Outcomes (1)

• differences of HbA1c change according to genetic variations of transporters

  Baseline and after 3 months of sitagliptin and metformin treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly Diagnosed Type 2 Diabetes Patients

You may qualify if:

• Newly Diagnosed Type 2 Diabetes Patients
• years old
• Taking sitagliptin and metformin for more than 3 months

You may not qualify if:

• Taking other oral hypoglycemic agents
• Taking medications can induce or inhibit transporters

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 433-721, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Doo-Yeoun Cho, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 26, 2011
• Study Start: July 1, 2011
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

KR (1)