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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
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- 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
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United States of America
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Alabama
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Arizona
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Kentucky
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Maryland
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Massachusetts
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Rhode Island
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Vallingby
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United Kingdom
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Antrim
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Cambridgeshire
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Fife
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Hampshire
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North Yorkshire
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Sussex
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Warwickshire
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Wiltshire
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Worcestershire
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United Kingdom
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Swan Lake

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00162240
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00162240