Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00162240




Registration number
NCT00162240
Ethics application status
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
27/04/2012

Titles & IDs
Public title
PPAR - Combination With Metformin
Scientific 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
Secondary ID [1] 0 0
CV168-022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2004
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Local Institution - Canberra
Recruitment hospital [2] 0 0
Local Institution - Sydney
Recruitment hospital [3] 0 0
Local Institution - Wollongong
Recruitment hospital [4] 0 0
Local Institution - Brisbane
Recruitment hospital [5] 0 0
Local Institution - Meadowbrook
Recruitment hospital [6] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Meadowbrook
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Capital Federal
Country [39] 0 0
Argentina
State/province [39] 0 0
Cordoba
Country [40] 0 0
Argentina
State/province [40] 0 0
Mendoza
Country [41] 0 0
Brazil
State/province [41] 0 0
Parana
Country [42] 0 0
Brazil
State/province [42] 0 0
Para
Country [43] 0 0
Brazil
State/province [43] 0 0
Rio Grande do Sul
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
British Columbia
Country [46] 0 0
Canada
State/province [46] 0 0
Manitoba
Country [47] 0 0
Canada
State/province [47] 0 0
Newfoundland and Labrador
Country [48] 0 0
Canada
State/province [48] 0 0
Nova Scotia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Canada
State/province [51] 0 0
Saskatchewan
Country [52] 0 0
France
State/province [52] 0 0
Albens
Country [53] 0 0
France
State/province [53] 0 0
Broglie
Country [54] 0 0
France
State/province [54] 0 0
Chartres
Country [55] 0 0
France
State/province [55] 0 0
Fabregues
Country [56] 0 0
France
State/province [56] 0 0
Gemenos
Country [57] 0 0
France
State/province [57] 0 0
Husseren Wesserling
Country [58] 0 0
France
State/province [58] 0 0
Labarthe Sur Leze
Country [59] 0 0
France
State/province [59] 0 0
Rosiers D'Egletons
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Mexico
State/province [61] 0 0
Baja California
Country [62] 0 0
Mexico
State/province [62] 0 0
Distrito Federal
Country [63] 0 0
Mexico
State/province [63] 0 0
Guanajuato
Country [64] 0 0
Mexico
State/province [64] 0 0
Morelos
Country [65] 0 0
Mexico
State/province [65] 0 0
Nuevo Leon
Country [66] 0 0
Mexico
State/province [66] 0 0
Yucatan
Country [67] 0 0
Mexico
State/province [67] 0 0
Durango
Country [68] 0 0
Peru
State/province [68] 0 0
Arequipa
Country [69] 0 0
Peru
State/province [69] 0 0
Lima
Country [70] 0 0
Puerto Rico
State/province [70] 0 0
Anasco
Country [71] 0 0
Puerto Rico
State/province [71] 0 0
Carolina
Country [72] 0 0
Puerto Rico
State/province [72] 0 0
Guaynabo
Country [73] 0 0
Puerto Rico
State/province [73] 0 0
Ponce
Country [74] 0 0
Puerto Rico
State/province [74] 0 0
Rio Piedras
Country [75] 0 0
Sweden
State/province [75] 0 0
Angelholm
Country [76] 0 0
Sweden
State/province [76] 0 0
Bjuv
Country [77] 0 0
Sweden
State/province [77] 0 0
Enskede
Country [78] 0 0
Sweden
State/province [78] 0 0
Farsta
Country [79] 0 0
Sweden
State/province [79] 0 0
Gothenburg
Country [80] 0 0
Sweden
State/province [80] 0 0
Helsingborg
Country [81] 0 0
Sweden
State/province [81] 0 0
Jarfalla
Country [82] 0 0
Sweden
State/province [82] 0 0
Landskrona
Country [83] 0 0
Sweden
State/province [83] 0 0
Leksand
Country [84] 0 0
Sweden
State/province [84] 0 0
Linkoping
Country [85] 0 0
Sweden
State/province [85] 0 0
Malmo
Country [86] 0 0
Sweden
State/province [86] 0 0
Odeshog
Country [87] 0 0
Sweden
State/province [87] 0 0
Savedalen
Country [88] 0 0
Sweden
State/province [88] 0 0
Sjuntorp
Country [89] 0 0
Sweden
State/province [89] 0 0
Stockholm
Country [90] 0 0
Sweden
State/province [90] 0 0
Trollhattan
Country [91] 0 0
Sweden
State/province [91] 0 0
Vallingby
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Antrim
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Cambridgeshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Derbyshire
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Devon
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Down
Country [97] 0 0
United Kingdom
State/province [97] 0 0
East Sussex
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Fife
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Hampshire
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Lanarkshire
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Lancashire
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Middlesex
Country [104] 0 0
United Kingdom
State/province [104] 0 0
North Yorkshire
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Sussex
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Warwickshire
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Wiltshire
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Worcestershire
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Swan Lake

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00162240