Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01242137
First received: November 14, 2010
Last updated: November 15, 2010
Last verified: October 2010
  Purpose

Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form. Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs from the sulfonylurea drug family, to whom Glibenclamide is included.

The investigators assumption is that patients with less active alleles of the enzyme may show lower dose requirements of the drug for glycemic control, when compared to patients homozygotes to wild-type alleles.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2009
Groups/Cohorts
Extensive metabolizers
Intermediate mtabolizers
Poor metabolizers

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetes type 2 patients treated with metformin and glibenclamide.

Criteria

Inclusion Criteria:

  • Tx with metformin and glibenclamide

Exclusion Criteria:

  • Tx which affecting the P450 2C9 action
  • Renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242137

Contacts
Contact: Amit Tirosh, Dr 972-52-4748989 tiroshamit@gmail.com

Locations
Israel
Assaf Harofe Medical Center Recruiting
Beer Yakov, Israel
Contact: Amit Tirosh, Dr    972-52-4748989    tiroshamit@gmail.com   
Principal Investigator: Amit Tirosh, Dr         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Assaf Harofe Medical Center
ClinicalTrials.gov Identifier: NCT01242137     History of Changes
Other Study ID Numbers: 169/09
Study First Received: November 14, 2010
Last Updated: November 15, 2010
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on October 29, 2014