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Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea



Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

For Condition: Diabetes Mellitus
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. ,
Synopsis: The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 25 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 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 Exclusion Criteria - Has type 1 diabetes mellitus - Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg. - History of congestive heart failure
Total Enrollment: 200

Location and Contact Information:

Baptist Diabetes Associates
Miami,  Florida,  33176
United States
 

Research Foundation of America
Los Angeles,  California,  90035
United States
 

Radiant Research - Minneapolis
Edina,  Minnesota,  55435
United States
 

Physician's Office
Portland,  Oregon,  97232
United States
 

Central Florida Clinical Studies
Ocoee,  Florida,  34761
United States
 

OCCR @ East Gate Medical Center
Cypress,  California,  90630
United States
 

International Institute of Clinical Research, Inc.
Ozark,  Alabama,  36360
United States
 

The Emory Clinic
Atlanta,  Georgia,  30322
United States
 

Fleetwood Medical Associates
Fleetwood,  Pennsylvania,  19522
United States
 

SFM Clinical Trials
Scotland,  Pennsylvania,  17254
United States
 

Progressive Clinical Research
Vista,  California,  92083
United States
 

Center for Diabetes and Endocrine Care
Hollywood,  Florida,  33021
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

East-West Medical Institute
Honolulu,  Hawaii,  96813
United States
 

McConnehey Family Medicine
Nampa,  Idaho,  83651
United States
 

Arizona Research Associates
Tucson,  Arizona,  85712
United States
 

Founders Research Corp.
Philadelphia,  Pennsylvania,  19124
United States
 

Clireco, Inc.
Tamarac,  Florida,  33321
United States
 

Sam Clinical Research Center
San Antonio,  Texas,  78229
United States
 

Clinical Trials of St. Jude Heritage Md Grp
Fullerton,  California,  92835
United States
 

Cleveland Clinic
Cleveland,  Ohio,  44195
United States
 

University of Miami, Diabetes Center
Miami,  Florida,  33136
United States
 

Physicians for Clinical Research
Camp Hill,  Pennsylvania,  17011
United States
 

University of Texas Southwestern Medical Center
Dallas,  Texas,  75390
United States
 

Physician's East
Greenville,  North Carolina,  27834
United States
 

University Physicians Internal Medicine
Huntington,  West Virginia,  25701
United States
 

Diablo Clinical Research, Inc.
Walnut Creek,  California,  94598
United States
 

Mercury Research, Inc.
Houston,  Texas,  77081
United States
 

Physician's Office
Peoria,  Illinois,  61614
United States
 

Radiant Research
Mogadorf,  Ohio,  44260
United States
 

Physician's Office
Miami,  Florida,  33136
United States
 

Heartland Medical PC
New Tazewell,  Tennessee,  37825
United States
 

Clinical Research, Inc.
Waltham,  Massachusetts,  02453
United States
 

Diabetes / Glandular Disease Research Associates
San Antonio,  Texas,  78229
United States
 

Physician's Office
Spokane,  Washington,  99216
United States
 

McGuire Research Institute
Richmond,  Virginia,  23249
United States
 


Additional Information:
Study ID Numbers:
  FA-614-0004; 
Study Start Date: February 2002
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036192

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