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

Completed · Phase 2

Conditions studied: Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00036192

Run by

Astellas Pharma Inc

People needed

200

Starts

2002-02-01

Expected to finish

2006-03-01

Last updated by the study team

2011-12-09

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 — Miami, Florida, United States
• University of Miami, Diabetes Center — Miami, Florida, United States
• Baptist Diabetes Associates — Miami, Florida, United States
• Central Florida Clinical Studies — Ocoee, Florida, United States
• Clireco, Inc. — Tamarac, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• East-West Medical Institute — Honolulu, Hawaii, United States
• McConnehey Family Medicine — Nampa, Idaho, United States
• Physician's Office — Peoria, Illinois, United States
• Clinical Research, Inc. — Waltham, Massachusetts, United States
• Radiant Research - Minneapolis — Edina, Minnesota, United States
• Physician's East — Greenville, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Radiant Research — Mogadorf, Ohio, United States
• Physician's Office — Portland, Oregon, United States
• Physicians for Clinical Research — Camp Hill, Pennsylvania, United States
• Fleetwood Medical Associates — Fleetwood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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