Clinical trial NCT00036192: Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2002-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

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