Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

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. Identifier: NCT01242137
Recruitment Status : Unknown
Verified October 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : November 16, 2010
Last Update Posted : November 16, 2010
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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 or disease

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : October 2009

Extensive metabolizers
Intermediate mtabolizers
Poor metabolizers

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 2 years ]

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
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

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 identifier (NCT number): 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

Responsible Party: Assaf Harofe Medical Center Identifier: NCT01242137     History of Changes
Other Study ID Numbers: 169/09
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: October 2010