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)
Clireco, Inc.
🇺🇸Tamarac, Florida, United States
Radiant Research - Minneapolis
🇺🇸Edina, Minnesota, United States
International Institute of Clinical Research, Inc.
🇺🇸Ozark, Alabama, United States
OCCR @ East Gate Medical Center
🇺🇸Cypress, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Progressive Clinical Research
🇺🇸Vista, California, United States
Physician's Office
🇺🇸Spokane, Washington, United States
Central Florida Clinical Studies
🇺🇸Ocoee, Florida, United States
East-West Medical Institute
🇺🇸Honolulu, Hawaii, United States
Physicians for Clinical Research
🇺🇸Camp Hill, Pennsylvania, United States
Fleetwood Medical Associates
🇺🇸Fleetwood, Pennsylvania, United States
SFM Clinical Trials
🇺🇸Scotland, Pennsylvania, United States
Heartland Medical PC
🇺🇸New Tazewell, Tennessee, United States
McGuire Research Institute
🇺🇸Richmond, Virginia, United States
Research Foundation of America
🇺🇸Los Angeles, California, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Mercury Research, Inc.
🇺🇸Houston, Texas, United States
Clinical Trials of St. Jude Heritage Md Grp
🇺🇸Fullerton, California, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Center for Diabetes and Endocrine Care
🇺🇸Hollywood, Florida, United States
McConnehey Family Medicine
🇺🇸Nampa, Idaho, United States
University of Miami, Diabetes Center
🇺🇸Miami, Florida, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Physician's East
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Founders Research Corp.
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Diabetes / Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States
Sam Clinical Research Center
🇺🇸San Antonio, Texas, United States
University Physicians Internal Medicine
🇺🇸Huntington, West Virginia, United States
Arizona Research Associates
🇺🇸Tucson, Arizona, United States
Clinical Research, Inc.
🇺🇸Waltham, Massachusetts, United States
Radiant Research
🇺🇸Mogadorf, Ohio, United States