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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242137
First Posted: November 16, 2010
Last Update Posted: November 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  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 ]

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

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • Tx with metformin and glibenclamide

Exclusion Criteria:

  • Tx which affecting the P450 2C9 action
  • Renal failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assaf Harofe Medical Center
ClinicalTrials.gov Identifier: NCT01242137     History of Changes
Other Study ID Numbers: 169/09
First Submitted: November 14, 2010
First Posted: November 16, 2010
Last Update Posted: November 16, 2010
Last Verified: October 2010