Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00036192
Collaborator
Astellas Pharma US, Inc. (Industry)
200
36
48.9
5.6
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Study Start Date
:
Feb 1, 2002
Actual Study Completion Date
:
Mar 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | International Institute of Clinical Research, Inc. | Ozark | Alabama | United States | 36360 |
| 2 | Arizona Research Associates | Tucson | Arizona | United States | 85712 |
| 3 | OCCR @ East Gate Medical Center | Cypress | California | United States | 90630 |
| 4 | Clinical Trials of St. Jude Heritage Md Grp | Fullerton | California | United States | 92835 |
| 5 | Research Foundation of America | Los Angeles | California | United States | 90035 |
| 6 | Progressive Clinical Research | Vista | California | United States | 92083 |
| 7 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 8 | Center for Diabetes and Endocrine Care | Hollywood | Florida | United States | 33021 |
| 9 | Physician's Office | Miami | Florida | United States | 33136 |
| 10 | University of Miami, Diabetes Center | Miami | Florida | United States | 33136 |
| 11 | Baptist Diabetes Associates | Miami | Florida | United States | 33176 |
| 12 | Central Florida Clinical Studies | Ocoee | Florida | United States | 34761 |
| 13 | Clireco, Inc. | Tamarac | Florida | United States | 33321 |
| 14 | The Emory Clinic | Atlanta | Georgia | United States | 30322 |
| 15 | East-West Medical Institute | Honolulu | Hawaii | United States | 96813 |
| 16 | McConnehey Family Medicine | Nampa | Idaho | United States | 83651 |
| 17 | Physician's Office | Peoria | Illinois | United States | 61614 |
| 18 | Clinical Research, Inc. | Waltham | Massachusetts | United States | 02453 |
| 19 | Radiant Research - Minneapolis | Edina | Minnesota | United States | 55435 |
| 20 | Physician's East | Greenville | North Carolina | United States | 27834 |
| 21 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 22 | Radiant Research | Mogadorf | Ohio | United States | 44260 |
| 23 | Physician's Office | Portland | Oregon | United States | 97232 |
| 24 | Physicians for Clinical Research | Camp Hill | Pennsylvania | United States | 17011 |
| 25 | Fleetwood Medical Associates | Fleetwood | Pennsylvania | United States | 19522 |
| 26 | Founders Research Corp. | Philadelphia | Pennsylvania | United States | 19124 |
| 27 | SFM Clinical Trials | Scotland | Pennsylvania | United States | 17254 |
| 28 | Heartland Medical PC | New Tazewell | Tennessee | United States | 37825 |
| 29 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 30 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 31 | Mercury Research, Inc. | Houston | Texas | United States | 77081 |
| 32 | Diabetes / Glandular Disease Research Associates | San Antonio | Texas | United States | 78229 |
| 33 | Sam Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 34 | McGuire Research Institute | Richmond | Virginia | United States | 23249 |
| 35 | Physician's Office | Spokane | Washington | United States | 99216 |
| 36 | University Physicians Internal Medicine | Huntington | West Virginia | United States | 25701 |
Sponsors and Collaborators
- Astellas Pharma Inc
- Astellas Pharma US, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00036192
Other Study ID Numbers:
- FA-614-0004
First Posted:
May 9, 2002
Last Update Posted:
Dec 9, 2011
Last Verified:
Dec 1, 2011