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

NCT ID: NCT00036192

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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FK614

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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International Institute of Clinical Research, Inc.

Ozark, Alabama, United States

Site Status

Arizona Research Associates

Tucson, Arizona, United States

Site Status

OCCR @ East Gate Medical Center

Cypress, California, United States

Site Status

Clinical Trials of St. Jude Heritage Md Grp

Fullerton, California, United States

Site Status

Research Foundation of America

Los Angeles, California, United States

Site Status

Progressive Clinical Research

Vista, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Center for Diabetes and Endocrine Care

Hollywood, Florida, United States

Site Status

Physician's Office

Miami, Florida, United States

Site Status

University of Miami, Diabetes Center

Miami, Florida, United States

Site Status

Baptist Diabetes Associates

Miami, Florida, United States

Site Status

Central Florida Clinical Studies

Ocoee, Florida, United States

Site Status

Clireco, Inc.

Tamarac, Florida, United States

Site Status

The Emory Clinic

Atlanta, Georgia, United States

Site Status

East-West Medical Institute

Honolulu, Hawaii, United States

Site Status

McConnehey Family Medicine

Nampa, Idaho, United States

Site Status

Physician's Office

Peoria, Illinois, United States

Site Status

Clinical Research, Inc.

Waltham, Massachusetts, United States

Site Status

Radiant Research - Minneapolis

Edina, Minnesota, United States

Site Status

Physician's East

Greenville, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Radiant Research

Mogadorf, Ohio, United States

Site Status

Physician's Office

Portland, Oregon, United States

Site Status

Physicians for Clinical Research

Camp Hill, Pennsylvania, United States

Site Status

Fleetwood Medical Associates

Fleetwood, Pennsylvania, United States

Site Status

Founders Research Corp.

Philadelphia, Pennsylvania, United States

Site Status

SFM Clinical Trials

Scotland, Pennsylvania, United States

Site Status

Heartland Medical PC

New Tazewell, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Mercury Research, Inc.

Houston, Texas, United States

Site Status

Diabetes / Glandular Disease Research Associates

San Antonio, Texas, United States

Site Status

Sam Clinical Research Center

San Antonio, Texas, United States

Site Status

McGuire Research Institute

Richmond, Virginia, United States

Site Status

Physician's Office

Spokane, Washington, United States

Site Status

University Physicians Internal Medicine

Huntington, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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FA-614-0004

Identifier Type: -

Identifier Source: org_study_id