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NCT00036192 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036192
Other study ID # FA-614-0004
Secondary ID
Status Completed
Phase Phase 2
First received May 8, 2002
Last updated December 8, 2011
Start date February 2002
Est. completion date March 2006

Study information
Verified date December 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• FK614

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

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

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