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Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

NCT ID: NCT01242137

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Extensive metabolizers

No interventions assigned to this group

Intermediate mtabolizers

No interventions assigned to this group

Poor metabolizers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Tx with metformin and glibenclamide

Exclusion Criteria

* Tx which affecting the P450 2C9 action
* Renal failure
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofe Medical Center

Locations

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Assaf Harofe Medical Center

Beer Yakov, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Amit Tirosh, Dr

Role: CONTACT

Phone: 972-52-4748989

Email: [email protected]

Facility Contacts

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Amit Tirosh, Dr

Role: primary

Other Identifiers

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169/09

Identifier Type: -

Identifier Source: org_study_id