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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01242137
Other study ID # 169/09
Secondary ID
Status Recruiting
Phase N/A
First received November 14, 2010
Last updated November 15, 2010
Start date October 2009

Study information

Verified date October 2010
Source Assaf-Harofeh Medical Center
Contact Amit Tirosh, Dr
Phone 972-52-4748989
Email tiroshamit@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- Tx with metformin and glibenclamide

Exclusion Criteria:

- Tx which affecting the P450 2C9 action

- Renal failure

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Assaf Harofe Medical Center Beer Yakov

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c 2 years No
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