Diabetes Mellitus, Type 2Phase 2NCT00212641
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
A Phase 2 study testing ONO-5129 in people with Diabetes Mellitus, Type 2, run by Ono Pharma USA Inc at 67 sites in United States.
Trial summary
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- ONO-5129
- How many people
- 105 participants
- Where
- 67 sitesUnited States
- Study dates
- Jun 2005to Oct 2007
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- FBG level > 140 mg/dL and < 270 mg/dL
- Fasting TG level < 500 mg/dL
- BMI of 22 to 40 kg/m2, inclusive
- Other Inclusion criteria as specified in the study protocol
Who cannot join
- Previous participation in an ONO-5129 protocol
- Previous treatment with TZD agents or other current antidiabetics
- History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
- Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
- Other exclusion criteria as specified in the study protocol
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602
Executive Health and Research Associates, Inc.
Atlanta, Georgia, 30342
Sagebrush Medical Plaza, Department of Family Medicine
Bakersfield, California, 93305
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Acadia Clinical Research, LLC
Bangor, Maine, 04401
Dolby Research, LLC
Baton Rouge, Louisiana, 70809
Apex Clinical Trials, Inc.
Birmingham, Alabama, 35209
Greystone Medical Research, LLC
Birmingham, Alabama, 35242
Capital City Family Medicine
Boise, Idaho, 83702
Orthopedic Health Care Clinic
Boise, Idaho, 83702
Sonora Clinical Research
Boise, Idaho, 83702
Mercury Street Medical
Butte, Montana, 59701
Professional Clinical Reserach -Great Lakes Family Care
Cadillac, Michigan, 49601
Med Search, LLC
Calera, Alabama, 35040
John Joseph, MD PA
Carrollton, Texas, 75007
Hyperion Clinical Trials, Inc.
Charleston, West Virginia, 25304
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Chicago Research Center, Inc.
Chicago, Illinois, 60634
New Horizons Clinical Research
Cincinnati, Ohio, 45252
Alliance Medical Reserach Group, Inc.
Clearwater, Florida, 33755
Bassett Healthcare
Cooperstown, New York, 13326
Renaissance Clinical Research
Dallas, Texas, 75235
Personal Physician Care
Delray Beach, Florida, 33445
Centennial Medical Group
Elkridge, Maryland, 21075
Family Medical Center
Foothill Ranch, California, 92610
DiGiovanna Family Care Center
Great Neck, New York, 11021
United Physicians Group - Endocrine Division
Great Neck, New York, 11021
Southeastern PA Medical Institute
Havertown, Pennsylvania, 19083
Century Clinical Research, Inc
Holly Hill, Florida, 32117
MCA Research
Houston, Texas, 77024
Southwest Houston Research, LTD
Houston, Texas, 77074
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Greenand Seidner Family Practice
Lansdale, Pennsylvania, 19446
Innovative Research of West Florida
Largo, Florida, 33770
Arapahoe Internal Medicine
Littleton, Colorado, 80120
Fallen Timbers Internal Medicine LLC
Maumee, Ohio, 43537
Cllinical Research Consultants
Medford, Oregon, 97504
Clinic of Physicians and Surgeons
Mesa, Arizona, 85201
Horizon Clinical Research Associates
Mesa, Arizona, 85206
Winthrop University Hospital
Mineola, New York, 11501
Prime-Care Clinical Research
Mission Viejo, California, 92691
Institute Diabetes and Metabolic Disease
Newark, Delaware, 19713
COR Clinical Reserch, LLC
Oklahoma City, Oklahoma, 73103
Specialty Medical Center
Pahrump, Nevada, 89048
Thomas Jefferson University Div of Endocrinology
Philadelphia, Pennsylvania, 19107
Founders Medical Practice
Philadelphia, Pennsylvania, 19152
Research Endeavors
Pittsburgh, Pennsylvania, 15238
Professional for Clinical Research
Plano, Texas, 75093
Research Across America
Plano, Texas, 75093
Covance Clinical Research Unit, Inc
Portland, Oregon, 92739
Michael A. Azorr, M.D.
Portland, Oregon, 97232
Synergy Medical Education Alliance
Saginaw, Michigan, 48602
Benjamin Garwood Research
San Antonio, Texas, 78216
WellMed at Northern Hills
San Antonio, Texas, 78217
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229
Diabetes and Glandular Disease - Westside office
San Antonio, Texas, 78237
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Heart of America Research
Shawnee, Kansas, 66216
Cochise Clinical Research
Sierra Vista, Arizona, 85635
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, 29681
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Encompass Clinical Research
Spring Valley, California, 91978
Medex Healthcare Research, Inc
St Louis, Missouri, 63108
Liberty Research Center
Tacoma, Washington, 98405
Orange County Research Center
Tustin, California, 92780
Quality Care Medical Center
Vista, California, 92084
About this study
Official title: Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- ONO-5129
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5129Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose at 8 weeks
Secondary outcomes (1)
Pharmacodynamic parameters at all time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 105 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph G Bisaha, Ph.D., Study director, Ono Pharma USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212641
- Sponsor's protocol ID
- ONO-5129POU006
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2005
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00212641
- Acronym / sponsor ID
- ONO-5129POU006
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Oct 2007 (actual)
- First posted
- 21 Sep 2005 (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 objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 Diabetes Mellitus
- FBG level > 140 mg/dL and < 270 mg/dL
- Fasting TG level < 500 mg/dL
- BMI of 22 to 40 kg/m2, inclusive
- Other Inclusion criteria as specified in the study protocol
Key exclusion criteria (5 listed)
- Previous participation in an ONO-5129 protocol
- Previous treatment with TZD agents or other current antidiabetics
- History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
- Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
- Other exclusion criteria as specified in the study protocol
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 |
|---|---|---|
| ONO-5129 | Drug | – |
Primary outcome
Fasting Blood Glucose at 8 weeks
1 secondary outcome
Pharmacodynamic parameters at all time points
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 11 Oct 2012.
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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.
Joseph G Bisaha, Ph.D. study director
Ono Pharma USA Inc
67 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 ONO-5129 in people with Diabetes Mellitus, Type 2, run by Ono Pharma USA Inc at 67 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 5 inclusion and 5 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 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.
What does the primary outcome measure?
Fasting Blood Glucose at 8 weeks. It is what the study was designed to measure, not a finding.
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 11 Oct 2012.