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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00162175




Registration number
NCT00162175
Ethics application status
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
14/09/2010

Titles & IDs
Public title
PPAR-COMBO With Sulfonylurea
Scientific title
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone
Secondary ID [1] 0 0
CV168-021
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Muraglitazar

Treatment: Drugs: Muraglitazar
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
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 . 1.5 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 MI (myocardial infarction), 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 or 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
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - Canberra
Recruitment hospital [2] 0 0
Local Institution - Wollongong
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Local Institution - Brisbane
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- Canberra
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- Wollongong
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- Brisbane
Recruitment outside Australia
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DE
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Worcestershire
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Swan Lane

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 Glyburide Therapy in Subjects with Type
2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00162175
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00162175