Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00036192
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
- Detailed Description
This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
International Institute of Clinical Research, Inc.
🇺🇸Ozark, Alabama, United States
Arizona Research Associates
🇺🇸Tucson, Arizona, United States
OCCR @ East Gate Medical Center
🇺🇸Cypress, California, United States
Clinical Trials of St. Jude Heritage Md Grp
🇺🇸Fullerton, California, United States
Research Foundation of America
🇺🇸Los Angeles, California, United States
Progressive Clinical Research
🇺🇸Vista, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Center for Diabetes and Endocrine Care
🇺🇸Hollywood, Florida, United States
Physician's Office
🇺🇸Spokane, Washington, United States
University of Miami, Diabetes Center
🇺🇸Miami, Florida, United States
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