Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
1 other identifier
interventional
200
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus
Started Feb 2002
Longer than P75 for phase_2 diabetes-mellitus
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 8, 2002
CompletedFirst Posted
Study publicly available on registry
May 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 9, 2011
December 1, 2011
May 8, 2002
December 8, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Has history of type 2 diabetes mellitus for at least 1 year
- Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched.
- Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months
You may not qualify if:
- Has type 1 diabetes mellitus
- Has uncontrolled hypertension, i.e., systolic BP \>170 or diastolic BP \> 95 mm Hg.
- History of congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (36)
International Institute of Clinical Research, Inc.
Ozark, Alabama, 36360, United States
Arizona Research Associates
Tucson, Arizona, 85712, United States
OCCR @ East Gate Medical Center
Cypress, California, 90630, United States
Clinical Trials of St. Jude Heritage Md Grp
Fullerton, California, 92835, United States
Research Foundation of America
Los Angeles, California, 90035, United States
Progressive Clinical Research
Vista, California, 92083, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
Physician's Office
Miami, Florida, 33136, United States
University of Miami, Diabetes Center
Miami, Florida, 33136, United States
Baptist Diabetes Associates
Miami, Florida, 33176, United States
Central Florida Clinical Studies
Ocoee, Florida, 34761, United States
Clireco, Inc.
Tamarac, Florida, 33321, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
East-West Medical Institute
Honolulu, Hawaii, 96813, United States
McConnehey Family Medicine
Nampa, Idaho, 83651, United States
Physician's Office
Peoria, Illinois, 61614, United States
Clinical Research, Inc.
Waltham, Massachusetts, 02453, United States
Radiant Research - Minneapolis
Edina, Minnesota, 55435, United States
Physician's East
Greenville, North Carolina, 27834, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Radiant Research
Mogadorf, Ohio, 44260, United States
Physician's Office
Portland, Oregon, 97232, United States
Physicians for Clinical Research
Camp Hill, Pennsylvania, 17011, United States
Fleetwood Medical Associates
Fleetwood, Pennsylvania, 19522, United States
Founders Research Corp.
Philadelphia, Pennsylvania, 19124, United States
SFM Clinical Trials
Scotland, Pennsylvania, 17254, United States
Heartland Medical PC
New Tazewell, Tennessee, 37825, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Mercury Research, Inc.
Houston, Texas, 77081, United States
Diabetes / Glandular Disease Research Associates
San Antonio, Texas, 78229, United States
Sam Clinical Research Center
San Antonio, Texas, 78229, United States
McGuire Research Institute
Richmond, Virginia, 23249, United States
Physician's Office
Spokane, Washington, 99216, United States
University Physicians Internal Medicine
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2002
First Posted
May 9, 2002
Study Start
February 1, 2002
Study Completion
March 1, 2006
Last Updated
December 9, 2011
Record last verified: 2011-12