Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

NCT00106808 | Completed Phase 3

• 1 other identifier: CV168-062
• Study Type: interventional
• Target: 1,440
• Locations: 14 countries
• Sites: 195

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Muraglitazar DRUG

Pioglitazone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (195)

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Madison, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Beverly Hills, California, United States

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Concord, California, United States

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Encinitas, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Roseville, California, United States

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Santa Monica, California, United States

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Colorado Springs, Colorado, United States

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Wilmington, Delaware, United States

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Boynton Beach, Florida, United States

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Charlotte Harbour, Florida, United States

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Chipley, Florida, United States

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Destin, Florida, United States

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Holly Hill, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Niceville, Florida, United States

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Panama City, Florida, United States

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Port Charlotte, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Calhoun, Georgia, United States

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Carrollton, Georgia, United States

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Dunwoody, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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North Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Cantonville, Maryland, United States

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Towson, Maryland, United States

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Westminister, Maryland, United States

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Swansea, Massachusetts, United States

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Cadillac, Michigan, United States

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Portage, Michigan, United States

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Richland, Michigan, United States

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Gulfport, Mississippi, United States

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Tupelo, Mississippi, United States

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City of Saint Peters, Missouri, United States

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Excelsior Springs, Missouri, United States

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Butte, Montana, United States

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Missoula, Montana, United States

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Bridgewater, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Binghamton, New York, United States

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Johnson City, New York, United States

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Mineola, New York, United States

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Northport, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Morehead City, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Barberton, Ohio, United States

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Bellbrook, Ohio, United States

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Canal Fulton, Ohio, United States

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Canfield, Ohio, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Mentor, Ohio, United States

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Youngstown, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philipsburg, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Fayetteville, Tennessee, United States

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Memphis, Tennessee, United States

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Selmer, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Midland, Texas, United States

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New Braunfels, Texas, United States

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Pearland, Texas, United States

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Rosenberg, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Salem, Virginia, United States

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Spokane, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Chacabuco, Chaco Province, Argentina

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Corrientes, Corrientes Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Broadmeadow, New South Wales, Australia

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Concord, New South Wales, Australia

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Randwick, New South Wales, Australia

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Westmead, New South Wales, Australia

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Brisbane, Queensland, Australia

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Cairns, Queensland, Australia

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Daw Park, South Australia, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Freemantle, Western Australia, Australia

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B. Rodolfo Teofilo, Ceará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Cerq. Cesar, São Paulo, Brazil

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Guama, São Paulo, Brazil

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Paulistânia, São Paulo, Brazil

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Rua Maestro, São Paulo, Brazil

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Ruo Maestro Cardim, São Paulo, Brazil

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Vila Mariana, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Antigonish, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Laval, Quebec, Canada

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Longueuil, Quebec, Canada

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Santiago, Región de Valparaíso, Chile

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Bangalore, India

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Chennai, India

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Hyderabad, India

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Kolkata, India

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Mumbai, India

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New Delhi, India

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Vellore, India

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Aguascalientes, Aguascalientes, Mexico

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Chihuahua City, Chihuahua, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Morelia, Michioacan, Mexico

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Monterrey, Nuevo León, Mexico

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Lima, Peru

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Cebu, Philippines

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Las Piñas, Philippines

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Manila, Philippines

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Pasig, Philippines

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Quezon, Philippines

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Quezon City, Philippines

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Kirov, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Saratov, Russia

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Yaroslavl, Russia

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Taoyuan Hsien, Taiwan

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Bangkok, Thailand

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Kong Kaen, Thailand

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Songkhla, Thailand

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Taipei City, Thailand

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Dniepropetrovsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Kyiv, Ukraine

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Odesa, Ukraine

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Simferopol, Ukraine

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

muraglitazar; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2005
• First Posted: April 1, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 14, 2010

Record last verified: 2007-09

Locations

BR (8); AR (5); IN (7); PH (6); CA (18); TW (3); CL (1); TH (4); UA (6); RU (5); PE (1); ME (7); US (112); AU (12)