PPAR - Combination With Metformin

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162240
• Other study ID #: CV168-022
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: April 26, 2012
• Start date: June 2003
• Est. completion date: May 2004

Study information

• Verified date: April 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Muraglitazar

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  France,  Korea, Republic of,  Mexico,  Peru,  Puerto Rico,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
Secondary	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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm