Clinical trial NCT00162240: PPAR - Combination With Metformin
Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Metabolics Diabetes New Onset
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 534
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: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* HbA1c \> - 7.0% and \< - 10.0 %
* Mean serum triglyceride \< - 600 mg/dL
* Body mass index \< - 41 kg/m2
* Fasting c-peptide \> - 1.0 ng/mL

Exclusion Criteria:

* History of myocardial infarction (MI)
* 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 renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease

Primary outcomes:
measure: compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Local Institution
state: Alabama
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Haleyville
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Mesa
country: United States
facility: Local Institution
state: Arizona
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Tucson
country: United States
facility: Local Institution
state: Arizona
city: Fayette
country: United States
facility: Local Institution
state: Arkansas
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Concord
country: United States
facility: Local Institution
state: California
city: Fountain Valley
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: Mission Viejo
country: United States
facility: Local Institution
state: California
city: Pasadena
country: United States
facility: Local Institution
state: California
city: Rolling Hills Estate
country: United States
facility: Local Institution
state: California
city: Roseville
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Spring Valley
country: United States
facility: Local Institution
state: California
city: Walnut Creek
country: United States
facility: Local Institution
state: California
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Littleton
country: United States
facility: Local Institution
state: Colorado
city: Loveland
country: United States
facility: Local Institution
state: Colorado
city: Wheat Ridge
country: United States
facility: Local Institution
state: Colorado
city: New Britain
country: United States
facility: Local Institution
state: Connecticut
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Wilmington
country: United States
facility: Local Institution
state: Delaware
city: Chipley
country: United States
facility: Local Institution
state: Florida
city: Cooper City
country: United States
facility: Local Institution
state: Florida
city: Kissimmee
country: United States
facility: Local Institution
state: Florida
city: Melbourne
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: Ocala
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Columbus
country: United States
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state: Georgia
city: Dunwoody
country: United States
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state: Georgia
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Overland Park
country: United States
facility: Local Institution
state: Kansas
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
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state: Kentucky
city: Richmond
country: United States
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state: Kentucky
city: SLidell
country: United States
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state: Louisiana
city: Chester
country: United States
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state: Maryland
city: Silver Spring
country: United States
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state: Maryland
city: Ayer
country: United States
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state: Massachusetts
city: Springfield
country: United States
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state: Massachusetts
city: Sudbury
country: United States
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state: Massachusetts
city: Lansing
country: United States
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state: Michigan
city: Arden Hills
country: United States
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state: Minnesota
city: Gulfport
country: United States
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state: Mississippi
city: Olive Branch
country: United States
facility: Local Institution
state: Mississippi
city: Rolling Fork
country: United States
facility: Local Institution
state: Mississippi
city: Excelsior Springs
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state: Missouri
city: Kansas City
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state: Missouri
city: Springfield
country: United States
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state: Missouri
city: St. Peters
country: United States
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state: Missouri
city: St.Louis
country: United States
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state: Missouri
city: Omaha
country: United States
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state: Nebraska
city: Toms River
country: United States
facility: Local Institution
state: New Jersey
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Buffalo
country: United States
facility: Local Institution
state: New York
city: New Hyde Park
country: United States
facility: Local Institution
state: New York
city: West Seneca
country: United States
facility: Local Institution
state: New York
city: Westfield
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Greensboro
country: United States
facility: Local Institution
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: High Point
country: United States
facility: Local Institution
state: North Carolina
city: Huntersville
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: Winston Salem
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Corvallis
country: United States
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state: Oregon
city: Eugene
country: United States
facility: Local Institution
state: Oregon
city: Hillsboro
country: United States
facility: Local Institution
state: Oregon
city: Portland
country: United States
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state: Oregon
city: Philadelphia
country: United States
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state: Pennsylvania
city: Warminster
country: United States
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state: Pennsylvania
city: Cranston
country: United States
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state: Rhode Island
city: Duncan
country: United States
facility: Local Institution
state: South Carolina
city: Greer
country: United States
facility: Local Institution
state: South Carolina
city: Simpsonville
country: United States
facility: Local Institution
state: South Carolina
city: Bristol
country: United States
facility: Local Institution
state: Tennessee
city: Kingsport
country: United States
facility: Local Institution
state: Tennessee
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Irving
country: United States
facility: Local Institution
state: Texas
city: Lake Jackson
country: United States
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state: Texas
city: Lubbock
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Springfield
country: United States
facility: Local Institution
state: Virginia
city: Virginia Beach
country: United States
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state: Virginia
city: Olympia
country: United States
facility: Local Institution
state: Washington
city: Renton
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Bahia Blanca
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
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city: Mendoza
country: Argentina
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city: Canberra
country: Australia
facility: Local Institution
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Wollongong
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Meadowbrook
country: Australia
facility: Local Institution
state: Queensland
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Belem
country: Brazil
facility: Local Institution
state: Para
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande do Sul
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Coquitlam
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Manuels
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: ST. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Oakville
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Thornhill
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Chicoutimi
country: Canada
facility: Local Institution
state: Quebec
city: Fleurimont
country: Canada
facility: Local Institution
state: Quebec
city: Granby
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: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Pointe-Claire
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Albens
country: France
facility: Local Institution
city: Broglie
country: France
facility: Local Institution
city: Chartres
country: France
facility: Local Institution
city: Fabregues
country: France
facility: Local Institution
city: Gemenos
country: France
facility: Local Institution
city: Husseren Wesserling
country: France
facility: Local Institution
city: Labarthe Sur Leze
country: France
facility: Local Institution
city: Rosiers D'Egletons
country: France
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Tijuana
country: Mexico
facility: Local Institution
state: Baja California
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Leon
country: Mexico
facility: Local Institution
state: Guanajuato
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Distrito Federal
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Arequipa
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Anasco
country: Puerto Rico
facility: Local Institution
city: Carolina
country: Puerto Rico
facility: Local Institution
city: Guaynabo
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
city: Angelholm
country: Sweden
facility: Local Institution
city: Bjuv
country: Sweden
facility: Local Institution
city: Enskede
country: Sweden
facility: Local Institution
city: Farsta
country: Sweden
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Helsingborg
country: Sweden
facility: Local Institution
city: Jarfalla
country: Sweden
facility: Local Institution
city: Landskrona
country: Sweden
facility: Local Institution
city: Leksand
country: Sweden
facility: Local Institution
city: Linkoping
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Odeshog
country: Sweden
facility: Local Institution
city: Savedalen
country: Sweden
facility: Local Institution
city: Sjuntorp
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Trollhattan
country: Sweden
facility: Local Institution
city: Vallingby
country: Sweden
facility: Local Institution
city: Carrickfergus
country: United Kingdom
facility: Local Institution
state: Antrim
city: Soham
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: Doncaster
country: United Kingdom
facility: Local Institution
state: Derbyshire
city: Paignton
country: United Kingdom
facility: Local Institution
state: Devon
city: Bangor
country: United Kingdom
facility: Local Institution
state: Down
city: Downpatrick
country: United Kingdom
facility: Local Institution
state: Down
city: Bexhill-On-Sea
country: United Kingdom
facility: Local Institution
state: East Sussex
city: High Valleyfield
country: United Kingdom
facility: Local Institution
state: Fife
city: Sunbury on Thames
country: United Kingdom
facility: Local Institution
state: Greater London
city: Aldershot
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Blackpool
country: United Kingdom
facility: Local Institution
state: Lancashire
city: Farnworth
country: United Kingdom
facility: Local Institution
state: Lancashire
city: Harrow
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Doncaster
country: United Kingdom
facility: Local Institution
state: North Yorkshire
city: Hastings
country: United Kingdom
facility: Local Institution
state: Sussex
city: Atherstone
country: United Kingdom
facility: Local Institution
state: Warwickshire
city: Nuneaton
country: United Kingdom
facility: Local Institution
state: Warwickshire
city: Bath
country: United Kingdom
facility: Local Institution
state: Wiltshire
city: Inkberrow
country: United Kingdom
facility: Local Institution
state: Worcestershire
city: Swan Lake
country: United Kingdom
facility: Local Institution
Study officials:
References: