Clinical trial NCT00106808: Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-04-01
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in HBA1c from baseline to Week 24
Secondary outcomes:
measure: Change for baseline in TG and HDL-C at Week 24
measure: Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
measure: To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Columbiana
country: United States
facility: Local Institution
state: Alabama
city: Madison
country: United States
facility: Local Institution
state: Alabama
city: Glendale
country: United States
facility: Local Institution
state: Arizona
city: Mesa
country: United States
facility: Local Institution
state: Arizona
city: Peoria
country: United States
facility: Local Institution
state: Arizona
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Concord
country: United States
facility: Local Institution
state: California
city: Encinitas
country: United States
facility: Local Institution
state: California
city: Fresno
country: United States
facility: Local Institution
state: California
city: La Jolla
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Los Gatos
country: United States
facility: Local Institution
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: Pasadena
country: United States
facility: Local Institution
state: California
city: Roseville
country: United States
facility: Local Institution
state: California
city: Santa Monica
country: United States
facility: Local Institution
state: California
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Wilmington
country: United States
facility: Local Institution
state: Delaware
city: Boynton Beach
country: United States
facility: Local Institution
state: Florida
city: Charlotte Harbour
country: United States
facility: Local Institution
state: Florida
city: Chipley
country: United States
facility: Local Institution
state: Florida
city: Destin
country: United States
facility: Local Institution
state: Florida
city: Holly Hill
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: New Port Richey
country: United States
facility: Local Institution
state: Florida
city: Niceville
country: United States
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state: Florida
city: Panama City
country: United States
facility: Local Institution
state: Florida
city: Port Charlotte
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Blue Ridge
country: United States
facility: Local Institution
state: Georgia
city: Calhoun
country: United States
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state: Georgia
city: Carrollton
country: United States
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state: Georgia
city: Dunwoody
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: North Chicago
country: United States
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state: Illinois
city: Evansville
country: United States
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Shawnee Mission
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Lafayette
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Cantonville
country: United States
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state: Maryland
city: Towson
country: United States
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state: Maryland
city: Westminister
country: United States
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state: Maryland
city: Swansea
country: United States
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state: Massachusetts
city: Cadillac
country: United States
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state: Michigan
city: Portage
country: United States
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state: Michigan
city: Richland
country: United States
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state: Michigan
city: Gulfport
country: United States
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state: Mississippi
city: Tupelo
country: United States
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state: Mississippi
city: Excelsior Springs
country: United States
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state: Missouri
city: St. Peters
country: United States
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state: Missouri
city: Butte
country: United States
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state: Montana
city: Missoula
country: United States
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state: Montana
city: Bridgewater
country: United States
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state: New Jersey
city: Cherry Hill
country: United States
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state: New Jersey
city: Binghamton
country: United States
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state: New York
city: Johnson City
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: Northport
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Greenville
country: United States
facility: Local Institution
state: North Carolina
city: Hickory
country: United States
facility: Local Institution
state: North Carolina
city: Morehead City
country: United States
facility: Local Institution
state: North Carolina
city: Salisbury
country: United States
facility: Local Institution
state: North Carolina
city: Wilmington
country: United States
facility: Local Institution
state: North Carolina
city: Barberton
country: United States
facility: Local Institution
state: Ohio
city: Bellbrook
country: United States
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state: Ohio
city: Canal Fulton
country: United States
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state: Ohio
city: Canfield
country: United States
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state: Ohio
city: Canton
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Lyndhurst
country: United States
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state: Ohio
city: Mentor
country: United States
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state: Ohio
city: Youngstown
country: United States
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state: Ohio
city: Eugene
country: United States
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state: Oregon
city: Medford
country: United States
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state: Oregon
city: Portland
country: United States
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state: Oregon
city: Philipsburg
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Reading
country: United States
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state: Pennsylvania
city: Tipton
country: United States
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state: Pennsylvania
city: West Grove
country: United States
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state: Pennsylvania
city: East Providence
country: United States
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state: Rhode Island
city: Greer
country: United States
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state: South Carolina
city: Mount Pleasant
country: United States
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state: South Carolina
city: Simpsonville
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Fayetteville
country: United States
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state: Tennessee
city: Memphis
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state: Tennessee
city: Selmer
country: United States
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state: Tennessee
city: Austin
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state: Texas
city: Corpus Christi
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Irving
country: United States
facility: Local Institution
state: Texas
city: Midland
country: United States
facility: Local Institution
state: Texas
city: New Braunfels
country: United States
facility: Local Institution
state: Texas
city: Pearland
country: United States
facility: Local Institution
state: Texas
city: Rosenberg
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Bountiful
country: United States
facility: Local Institution
state: Utah
city: Falls Church
country: United States
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state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Salem
country: United States
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state: Virginia
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Chacabuco
country: Argentina
facility: Local Institution
state: Chaco
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Corrientes
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Broadmeadow
country: Australia
facility: Local Institution
state: New South Wales
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Daw Park
country: Australia
facility: Local Institution
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Geelong
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Freemantle
country: Australia
facility: Local Institution
state: Western Australia
city: B. Rodolfo Teofilo
country: Brazil
facility: Local Institution
state: Ceara
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Bandeirantes
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Cerq. Cesar
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Guama
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rua Maestro
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Ruo Maestro Cardim
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Vila Mariana
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Coquitlam
country: Canada
facility: Local Institution
state: British Columbia
city: Langley
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Antigonish
country: Canada
facility: Local Institution
state: Nova Scotia
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Cambridge
country: Canada
facility: Local Institution
state: Ontario
city: Kitchener
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Markham
country: Canada
facility: Local Institution
state: Ontario
city: North Bay
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Longueuil
country: Canada
facility: Local Institution
state: Quebec
city: Santiago
country: Chile
facility: Local Institution
state: Valparaiso
city: Bangalore
country: India
facility: Local Institution
city: Calcutta
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Vellore
country: India
facility: Local Institution
city: Mexico D.F.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Chihuahua
country: Mexico
facility: Local Institution
city: Lima 1
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Cebu
country: Philippines
facility: Local Institution
city: Las Pinas
country: Philippines
facility: Local Institution
city: Manila City
country: Philippines
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Pasig City
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Quezon
country: Philippines
facility: Local Institution
city: Kirov
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan Hsien
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Kong Kaen
country: Thailand
facility: Local Institution
city: Songkla
country: Thailand
facility: Local Institution
city: Taipei City
country: Thailand
facility: Local Institution
city: Dniepropetrovsk
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kiev
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Odessa
country: Ukraine
facility: Local Institution
city: Simferopol
country: Ukraine
facility: Local Institution
Study officials:
References: