Type 2 DiabetesPhase 3NCT00240370
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics
A Phase 3 study testing Muraglitazar in people with Type 2 Diabetes, run by Bristol-Myers Squibb at 85 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Muraglitazar
- How many people
- 1,159 participants
- Where
- 85 sitesin 4 countries
- Study dates
- Oct 2003to Mar 2005
- 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
- Type 2 diabetics
- HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
- Fasting C-peptide ≥1.0 ng/mL
- BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL
Who cannot join
- symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study
- history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Trial locations and contacts
85 sites in 4 countries.
85 sites in 4 countries
United States70 sites
Local Institution
Altamonte Springs, Florida
Local Institution
Anaheim, California
Local Institution
Artesia, California
Local Institution
Austin, Texas
Local Institution
Baltimore, Maryland
Local Institution
Bellbrook, Ohio
Local Institution
Birmingham, Alabama
Local Institution
Bluefield, West Virginia
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Camp Hill, Pennsylvania
Local Institution
Carlisle, Arkansas
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Carrollton, Texas
Local Institution
Cary, North Carolina
Local Institution
Charleston, South Carolina
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Charlotte, North Carolina
Local Institution
Clinton, South Carolina
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Columbiana, Alabama
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Corpus Christi, Texas
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Dallas, Texas
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Denver, Colorado
Local Institution
Detroit, Michigan
Local Institution
East Providence, Rhode Island
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Encino, California
Local Institution
Encintas, California
Local Institution
Endwell, New York
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Evansville, Indiana
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Fresno, California
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Gulfport, Mississippi
Local Institution
Hamden, Connecticut
Local Institution
Hollywood, Florida
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Honolulu, Hawaii
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Houston, Texas
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Jacksonville, Florida
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Jonesboro, Arkansas
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Lafayette, Indiana
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Lebanon, Virginia
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Little Rock, Arkansas
Local Institution
Long Beach, California
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Los Angeles, California
Local Institution
Maumee, Ohio
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Melrose Park, Pennsylvania
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
Local Institution
Midland, Texas
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New Orleans, Louisiana
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New Port Richie, Florida
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Northridge, California
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Peoria, Arizona
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Pine Bluff, Arkansas
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Pittsburgh, Pennsylvania
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Portland, Oregon
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Raleigh, North Carolina
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Rudd, North Carolina
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Saint Cloud, Florida
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Salt Lake City, Utah
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San Antonio, Texas
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Sherwood, Arkansas
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Shreveport, Louisiana
Local Institution
Spokane, Washington
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St Louis, Missouri
Local Institution
Statesville, North Carolina
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Tacoma, Washington
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Thornville, Ohio
Local Institution
West Chester, Pennsylvania
Local Institution
West Palm Beach, Florida
Local Institution
Wilmington, North Carolina
Local Institution
Winston-Salem, North Carolina
Local Institution
Youngwood, Pennsylvania
Canada7 sites
Local Institution
Bonaventure, Quebec
Local Institution
Drummondville, Quebec
Local Institution
Montreal, Quebec
Local Institution
Red Deer, Alberta
Local Institution
Rimouski, Quebec
Local Institution
Sarnia, Ontario
Local Institution
Vancouver, British Columbia
Mexico6 sites
Local Institution
Aguascalientes, Aguascalientes
Local Institution
Chihuahua City, Chihuahua
Local Institution
Cuernavaca, Morelos
Local Institution
Mexico, Durango
Local Institution
Mexico City, Mexico City
Local Institution
Tijuana, Estado de Baja California
About this study
Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.
- Conditions
- Type 2 Diabetes
- 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.
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
Secondary outcomes (2)
Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in
hs-CRP from baseline to W24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2003
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 1,159 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240370
- Sponsor's protocol ID
- CV168-025
- Status last verified
- Jun 2008
- First submitted
- 17 Oct 2005
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT00240370
- Acronym / sponsor ID
- CV168-025
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,159 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Mar 2005 (actual)
- First posted
- 18 Oct 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 purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.
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 (4 listed)
- Type 2 diabetics
- HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.
- Fasting C-peptide ≥1.0 ng/mL
- BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL
Key exclusion criteria (3 listed)
- symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study
- history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling
- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or 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
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin
2 secondary outcomes
Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in
hs-CRP from baseline to W24
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 14 Sep 2010.
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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.
85 sites in 4 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 Type 2 Diabetes, run by Bristol-Myers Squibb at 85 sites in 4 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 4 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 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Canada, Mexico, Puerto Rico. 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?
Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin. 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 14 Sep 2010.