NCT01082796

Brief Summary

Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
Last Updated

March 9, 2010

Status Verified

November 1, 2009

First QC Date

March 4, 2010

Last Update Submit

March 8, 2010

Conditions

GenotypePharmacokinetic

Study Arms (2)

CYP2C19 EMs group

OTHER

cyp2c19\*1/\*1 carriers

Drug: Glipizide

CYP2C19 PMs group

OTHER

cyp2c19\*2/\*2 or \*2/\*3

Drug: Glipizide

Interventions

GlipizideDRUG

Each subject received 5 mg glipizide extended release tablet once daily for 7 days.

Also known as: Glucotrol XL®
CYP2C19 EMs groupCYP2C19 PMs group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy
  • nonsmokers

You may not qualify if:

  • BMI \> 24 or BMI \< 19
  • had any family history of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmant of Clinical Pharmacology, the First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Related Links

MeSH Terms

Interventions

Glipizide

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsSulfonesSulfur CompoundsOrganic Chemicals

Study Officials

  • Da F Zhong, PH.D

    Shanghai Institute of Materia Medica, Chinese Academy of Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 9, 2010

Study Start

November 1, 2009

Study Completion

January 1, 2010

Last Updated

March 9, 2010

Record last verified: 2009-11

Locations

CN(1)