Diabetes MellitusPhase 2NCT00036192
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
A Phase 2 study testing FK614 in people with Diabetes Mellitus, run by Astellas Pharma Inc at 36 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FK614
- How many people
- 200 participants
- Where
- 36 sitesUnited States
- Study dates
- Feb 2002to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has type 1 diabetes mellitus
- Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg.
- History of congestive heart failure
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
The Emory Clinic
Atlanta, Georgia, 30322
Physicians for Clinical Research
Camp Hill, Pennsylvania, 17011
Cleveland Clinic
Cleveland, Ohio, 44195
OCCR @ East Gate Medical Center
Cypress, California, 90630
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Radiant Research - Minneapolis
Edina, Minnesota, 55435
Fleetwood Medical Associates
Fleetwood, Pennsylvania, 19522
Clinical Trials of St. Jude Heritage Md Grp
Fullerton, California, 92835
Physician's East
Greenville, North Carolina, 27834
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
East-West Medical Institute
Honolulu, Hawaii, 96813
Baylor College of Medicine
Houston, Texas, 77030
Mercury Research, Inc.
Houston, Texas, 77081
University Physicians Internal Medicine
Huntington, West Virginia, 25701
Research Foundation of America
Los Angeles, California, 90035
Physician's Office
Miami, Florida, 33136
University of Miami, Diabetes Center
Miami, Florida, 33136
Baptist Diabetes Associates
Miami, Florida, 33176
Radiant Research
Mogadorf, Ohio, 44260
McConnehey Family Medicine
Nampa, Idaho, 83651
Heartland Medical PC
New Tazewell, Tennessee, 37825
Central Florida Clinical Studies
Ocoee, Florida, 34761
International Institute of Clinical Research, Inc.
Ozark, Alabama, 36360
Physician's Office
Peoria, Illinois, 61614
Founders Research Corp.
Philadelphia, Pennsylvania, 19124
Physician's Office
Portland, Oregon, 97232
McGuire Research Institute
Richmond, Virginia, 23249
Diabetes / Glandular Disease Research Associates
San Antonio, Texas, 78229
Sam Clinical Research Center
San Antonio, Texas, 78229
SFM Clinical Trials
Scotland, Pennsylvania, 17254
Physician's Office
Spokane, Washington, 99216
Clireco, Inc.
Tamarac, Florida, 33321
Arizona Research Associates
Tucson, Arizona, 85712
Progressive Clinical Research
Vista, California, 92083
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Clinical Research, Inc.
Waltham, Massachusetts, 02453
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- FK614
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK614Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startFeb 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036192
- Sponsor's protocol ID
- FA-614-0004
- Status last verified
- Dec 2011
- First submitted
- 8 May 2002
- Last updated
- 9 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
- ClinicalTrials.gov ID
- NCT00036192
- Acronym / sponsor ID
- FA-614-0004
- Conditions
- Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Feb 2002
- Study completion
- Mar 2006 (actual)
- First posted
- 9 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Has type 1 diabetes mellitus
- Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg.
- History of congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FK614 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK614 in people with Diabetes Mellitus, run by Astellas Pharma Inc at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011.