Diabetes, Type 2Phase 3NCT00246987
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 3 study testing Muraglitazar in people with Diabetes, Type 2, run by Bristol-Myers Squibb at 130 sites in 7 countries.
Trial summary
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- Muraglitazar
- How many people
- 341 participants
- Where
- 130 sitesin 7 countries
- Study dates
- Jun 2003to Apr 2004
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Type 2 diabetes
- Drug Naive
- HbA1c >= 7.0% and <= 10.0%
- Body Mass Index <= 41 kg/m2
- Serum TG <= 600 mg/dL
Who cannot join
- Symptomatic Type 2 diabetes
- History of bladder cancer
- History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Trial locations and contacts
130 sites in 7 countries.
130 sites in 7 countries
United States82 sites
Local Institution
Altamonte Springs, Florida
Local Institution
Anderson, South Carolina
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Anniston, Alabama
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Birmingham, Alabama
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Brandon, Florida
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Charlotte, North Carolina
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Chesterfield, Missouri
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Chicago, Illinois
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Chipley, Florida
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Colorado Springs, Colorado
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Concord, California
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Coral Gables, Florida
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East Providence, Rhode Island
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Edmonds, Washington
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Elizabeth, New Jersey
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Endwell, New York
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Eugene, Oregon
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Fayetteville, Arizona
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Federal Way, Washington
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Fort Worth, Texas
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Fountain Valley, California
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Franklin, Ohio
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Golden, Colorado
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Greer, South Carolina
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Gulfport, Mississippi
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Haleyville, Alabama
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High Point, North Carolina
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Hoover, Alabama
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Hot Springs, Arizona
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Johnston, Rhode Island
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Kansas City, Missouri
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Kissimmee, Florida
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Knoxville, Tennessee
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Lexington, Kentucky
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Littleton, Colorado
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Long Beach, California
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Longwood, Florida
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Los Gatos, California
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Lubbock, Texas
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Madisonville, Kentucky
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Melbourne, Florida
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Memphis, Tennessee
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Mesa, Arizona
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Milwaukee, Wisconsin
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Morehead City, North Carolina
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Mt. Pleasant, South Carolina
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New Britain, Connecticut
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New Port Richie, Florida
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Newark, Ohio
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Ocala, Florida
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Olympia, Washington
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Overland Park, Kansas
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pinellas Park, Florida
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Portland, Oregon
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Providence, Rhode Island
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Raleigh, California
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Reading, Pennsylvania
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Richmond, Virginia
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Roseville, California
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Saint Peters, Mississippi
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Salisbury, North Carolina
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Salt Lake City, Utah
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San Angelo, Texas
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San Antonio, Texas
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San Diego, California
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Shawnee Mission, Kansas
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Shreveport, Louisiana
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Spokane, Washington
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Spring Valley, California
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Springfield, Missouri
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Toms River, New Jersey
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Tucson, Arizona
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Tulsa, Arizona
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Tustin, California
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Vancouver, Washington
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Virginia Beach, Virginia
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Warminster, Pennsylvania
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West Seneca, New York
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Winston-Salem, North Carolina
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Zanesville, Ohio
Canada25 sites
Local Institution
Calgary, Alberta
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Charlottetown, Prince Edward Island
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Chicoutimi, Quebec
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Coquitlam, British Columbia
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Drummondville, Quebec
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Edmonton, Alberta
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Granby, Quebec
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Halifax, Nova Scotia
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Laval, Quebec
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Longueuil, Quebec
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Manuels, Newfoundland and Labrador
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Markham, Ontario
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Montreal, Quebec
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Oakville, Ontario
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Ottawa, Ontario
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Pointe-Claire, Quebec
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Regina, Saskatchewan
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Saint-Lambert, Quebec
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Saskatoon, Saskatchewan
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St. John's, Newfoundland and Labrador
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Ste-Foy, Quebec
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Thornhill, Ontario
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Thunder Bay, Ontario
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Toronto, Ontario
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Winnipeg, Manitoba
Australia9 sites
Local Institution
Adelaide, South Australia
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Canberra, New South Wales
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Kippa-Ring, Queensland
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Launceston, Tasmania
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Meadowbrook, Queensland
Tasmania
Melbourne, Victoria
Local Institution
Sydney, New South Wales
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Wollongong, New South Wales
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Woodville, South Australia
Poland5 sites
Local Institution
Krakow
Local Institution
Lodz
Local Institution
Mroków
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Warsaw
Local Institution
Zabrze
Mexico4 sites
Local Institution
Aguascalientes, Aguascalientes
Local Institution
Cuernavaca, Morelos
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Durango, Durango
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Mexico City, Mexico City
Puerto Rico3 sites
Local Institution
Anasco
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Ponce
Local Institution
Rio Pieoras
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.
- Conditions
- Diabetes, Type 2
- Being tested
- Muraglitazar
- 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.
MuraglitazarDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to Week 24
Secondary outcomes (1)
Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startJun 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 341 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246987
- Sponsor's protocol ID
- CV168-018
- Status last verified
- Apr 2012
- First submitted
- 28 Oct 2005
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00246987
- Acronym / sponsor ID
- CV168-018
- Conditions
- Diabetes, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 1 Nov 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.
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with Type 2 diabetes
- Drug Naive
- HbA1c >= 7.0% and <= 10.0%
- Body Mass Index <= 41 kg/m2
- Serum TG <= 600 mg/dL
Key exclusion criteria (3 listed)
- Symptomatic Type 2 diabetes
- History of bladder cancer
- History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
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 |
|---|---|---|
| Muraglitazar | Drug | – |
Primary outcome
Change in HbA1c from baseline to Week 24
1 secondary outcome
Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.
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 27 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
130 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Muraglitazar in people with Diabetes, Type 2, run by Bristol-Myers Squibb at 130 sites in 7 countries.
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 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, Canada, Australia, Poland, Mexico and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in HbA1c from baseline to Week 24. 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 27 Apr 2012.