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Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Assaf-Harofeh Medical Center Identifier:
First received: November 14, 2010
Last updated: November 15, 2010
Last verified: October 2010

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.


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 ]

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


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetes type 2 patients treated with metformin and glibenclamide.

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 identifier: NCT01242137

Contact: Amit Tirosh, Dr 972-52-4748989

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

Responsible Party: Assaf Harofe Medical Center Identifier: NCT01242137     History of Changes
Other Study ID Numbers: 169/09
Study First Received: November 14, 2010
Last Updated: November 15, 2010 processed this record on September 21, 2017