Type 2 Diabetes MellitusPhase 3NCT00106808
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
A Phase 3 study testing Muraglitazar and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 195 sites in 14 countries.
Trial summary
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Muraglitazar and Pioglitazone
- How many people
- 1,440 participants
- Where
- 195 sitesin 14 countries
- Study dates
- Aug 2005to Aug 2006
- 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 Diabetes
- HbA1c > = 8.0% and < = 12.0%
- Serum triglyceride concentration < = 600 mg/dL
- Fasting c-peptide > = 1.0 ng/ml
- Body mass index < = 41 kg/m2
- Drug naive patients
Who cannot join
- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
- Women of child Bearing Potential
- Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
- History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Trial locations and contacts
195 sites in 14 countries.
195 sites in 14 countries
United States112 sites
Local Institution
Atlanta, Georgia
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Austin, Texas
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Baltimore, Maryland
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Barberton, Ohio
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Bellbrook, Ohio
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Beverly Hills, California
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Binghamton, New York
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Birmingham, Alabama
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Blue Ridge, Georgia
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Bountiful, Utah
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Boynton Beach, Florida
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Bridgewater, New Jersey
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Butte, Montana
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Cadillac, Michigan
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Calhoun, Georgia
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Canal Fulton, Ohio
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Canfield, Ohio
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Canton, Ohio
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Cantonville, Maryland
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Carrollton, Georgia
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Charlotte, North Carolina
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Charlotte Harbour, Florida
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Chattanooga, Tennessee
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Cherry Hill, New Jersey
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Chicago, Illinois
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Chipley, Florida
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City of Saint Peters, Missouri
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Colorado Springs, Colorado
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Columbiana, Alabama
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Columbus, Ohio
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Concord, California
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Corpus Christi, Texas
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Destin, Florida
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Dunwoody, Georgia
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East Providence, Rhode Island
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Encinitas, California
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Eugene, Oregon
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Evansville, Indiana
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Excelsior Springs, Missouri
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Falls Church, Virginia
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Fayetteville, Tennessee
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Fresno, California
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Glendale, Arizona
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Greenville, North Carolina
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Greer, South Carolina
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Gulfport, Mississippi
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Hickory, North Carolina
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Holly Hill, Florida
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Houston, Texas
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Indianapolis, Indiana
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Irving, Texas
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Jacksonville, Florida
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Johnson City, New York
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La Jolla, California
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Lafayette, Louisiana
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Los Angeles, California
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Los Gatos, California
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Louisville, Kentucky
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Lyndhurst, Ohio
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Madison, Alabama
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Marietta, Georgia
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Medford, Oregon
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Memphis, Tennessee
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Mentor, Ohio
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Mesa, Arizona
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Miami, Florida
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Midland, Texas
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Mineola, New York
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Missoula, Montana
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Morehead City, North Carolina
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Mt. Pleasant, South Carolina
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New Braunfels, Texas
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New Port Richey, Florida
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Niceville, Florida
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Norfolk, Virginia
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North Chicago, Illinois
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Northport, New York
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Orange, California
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Panama City, Florida
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Pasadena, California
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Pearland, Texas
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Peoria, Arizona
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Philipsburg, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Port Charlotte, Florida
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Portage, Michigan
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Portland, Oregon
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Reading, Pennsylvania
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Richland, Michigan
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Rosenberg, Texas
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Roseville, California
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Salem, Virginia
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Salisbury, North Carolina
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San Antonio, Texas
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Santa Monica, California
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Scottsdale, Arizona
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Selmer, Tennessee
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Shawnee Mission, Kansas
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Shreveport, Louisiana
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Simpsonville, South Carolina
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Spokane, Washington
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Swansea, Massachusetts
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Tipton, Pennsylvania
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Towson, Maryland
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Tupelo, Mississippi
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West Grove, Pennsylvania
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Westminister, Maryland
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Wichita, Kansas
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Wilmington, Delaware
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Wilmington, North Carolina
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Youngstown, Ohio
Canada18 sites
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Antigonish Nova Scotia, Nova Scotia
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Cambridge, Ontario
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Coquitlam, British Columbia
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Edmonton, Alberta
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Kitchener, Ontario
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Langley, British Columbia
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Laval, Quebec
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London, Ontario
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Longueuil, Quebec
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Markham, Ontario
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North Bay, Ontario
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Ottawa, Ontario
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Windsor, Ontario
Australia12 sites
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Box Hill, Victoria
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Brisbane, Queensland
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Broadmeadow, New South Wales
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Cairns, Queensland
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Concord, New South Wales
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Daw Park, South Australia
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Fitzroy, Victoria
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Freemantle, Western Australia
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Geelong, Victoria
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Melbourne, Victoria
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Randwick, New South Wales
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Westmead, New South Wales
Brazil8 sites
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B. Rodolfo Teofilo, Ceará
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Cerq. Cesar, São Paulo
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Guama, São Paulo
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Paulistânia, São Paulo
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Porto Alegre, Rio Grande do Sul
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Rua Maestro, São Paulo
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Ruo Maestro Cardim, São Paulo
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Vila Mariana, São Paulo
India7 sites
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Bangalore
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Chennai
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Hyderabad
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Kolkata
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Mumbai
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New Delhi
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Vellore
Mexico7 sites
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Aguascalientes, Aguascalientes
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Chihuahua City, Chihuahua
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Guadalajara, Jalisco
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Morelia, Michioacan
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Zapopan, Jalisco
Philippines6 sites
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Cebu
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Las Piñas
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Manila
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Pasig
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Quezon
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Quezon City
Ukraine6 sites
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Dniepropetrovsk
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Kharkiv
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Kiev
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Kyiv
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Odesa
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Simferopol
Argentina5 sites
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Buenos Aires, Buenos Aires
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Chacabuco, Chaco Province
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Córdoba, Córdoba Province
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Corrientes, Corrientes Province
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Santa Fe, Santa Fe Province
Russia5 sites
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Kirov
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Moscow
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Saint Petersburg
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Saratov
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Yaroslavl
Thailand4 sites
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Bangkok
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Kong Kaen
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Songkhla
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Taipei City
Taiwan3 sites
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Kaohsiung City
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Taipei
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Taoyuan Hsien
About this study
Official title: A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Muraglitazar, Pioglitazone
- Keywords
- Type 2 Diabetes
- 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
PioglitazoneDrug
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 (3)
Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 1,440 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106808
- Sponsor's protocol ID
- CV168-062
- Status last verified
- Sep 2007
- First submitted
- 31 Mar 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 Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00106808
- Acronym / sponsor ID
- CV168-062
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 1 Apr 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 compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.
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 (6 listed)
- Type 2 Diabetes
- HbA1c > = 8.0% and < = 12.0%
- Serum triglyceride concentration < = 600 mg/dL
- Fasting c-peptide > = 1.0 ng/ml
- Body mass index < = 41 kg/m2
Key exclusion criteria (4 listed)
- History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
- Women of child Bearing Potential
- Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
- History of renal disease, bladder cancer, 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 | – |
| Pioglitazone | Drug | – |
Primary outcome
Change in HBA1c from baseline to Week 24
3 secondary outcomes
Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
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.
195 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Muraglitazar and Pioglitazone in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 195 sites in 14 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 6 inclusion and 4 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 195 sites in United States, Canada, Australia, Brazil, India and 9 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 14 Sep 2010.