Status:
COMPLETED
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glybur...
Eligibility Criteria
Inclusion
- adult patients, aged 18-75 years;
- type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
- untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.
Exclusion
- type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
- diabetic neuropathy, retinopathy or nephropathy;
- patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00388986
Start Date
October 1 2006
End Date
July 1 2007
Last Update
November 2 2016
Active Locations (4)
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1
Cypress, California, United States, 90630
2
Honolulu, Hawaii, United States, 96813
3
Buffalo, New York, United States, NY 14215
4
San Antonio, Texas, United States, 78229