Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00036192

Purpose

The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: FK614	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: FK 614

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	200
Study Start Date:	February 2002

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036192

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Locations

United States, Alabama
International Institute of Clinical Research, Inc.
Ozark, Alabama, United States, 36360
United States, Arizona
Arizona Research Associates
Tucson, Arizona, United States, 85712
United States, California
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
OCCR @ East Gate Medical Center
Cypress, California, United States, 90630
Research Foundation of America
Los Angeles, California, United States, 90035
Progressive Clinical Research
Vista, California, United States, 92083
Clinical Trials of St. Jude Heritage Md Grp
Fullerton, California, United States, 92835
United States, Florida
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Central Florida Clinical Studies
Ocoee, Florida, United States, 34761
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Physician's Office
Miami, Florida, United States, 33136
University of Miami, Diabetes Center
Miami, Florida, United States, 33136
Clireco, Inc.
Tamarac, Florida, United States, 33321
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Hawaii
East-West Medical Institute
Honolulu, Hawaii, United States, 96813
United States, Idaho
McConnehey Family Medicine
Nampa, Idaho, United States, 83651
United States, Illinois
Physician's Office
Peoria, Illinois, United States, 61614
United States, Massachusetts
Clinical Research, Inc.
Waltham, Massachusetts, United States, 02453
United States, Minnesota
Radiant Research - Minneapolis
Edina, Minnesota, United States, 55435
United States, North Carolina
Physician's East
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Radiant Research
Mogadorf, Ohio, United States, 44260
United States, Oregon
Physician's Office
Portland, Oregon, United States, 97232
United States, Pennsylvania
SFM Clinical Trials
Scotland, Pennsylvania, United States, 17254
Founders Research Corp.
Philadelphia, Pennsylvania, United States, 19124
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States, 17011
Fleetwood Medical Associates
Fleetwood, Pennsylvania, United States, 19522
United States, Tennessee
Heartland Medical PC
New Tazewell, Tennessee, United States, 37825
United States, Texas
Diabetes / Glandular Disease Research Associates
San Antonio, Texas, United States, 78229
Mercury Research, Inc.
Houston, Texas, United States, 77081
Sam Clinical Research Center
San Antonio, Texas, United States, 78229
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
McGuire Research Institute
Richmond, Virginia, United States, 23249
United States, Washington
Physician's Office
Spokane, Washington, United States, 99216
United States, West Virginia
University Physicians Internal Medicine
Huntington, West Virginia, United States, 25701

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

More Information

No publications provided

Study ID Numbers:	FA-614-0004
Study First Received:	May 8, 2002
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00036192 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009