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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00240383




Registration number
NCT00240383
Ethics application status
Date submitted
17/10/2005
Date registered
18/10/2005
Date last updated
14/09/2010

Titles & IDs
Public title
Dose Ranging Study With LT, Monotherapy, PPAR
Scientific title
A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
CV168-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus II 0 0
Condition category
Condition code

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
To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 1. HbA1c > 7.0% and = 10.0% obtained at the Screening visit.

- 2. Men and women, 18-70 years of age Established Type 2 diabetes
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater
than 10% weight loss during the last three months.

- 2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more
than three consecutive or a total of seven non-consecutive days during the four weeks
prior to screening.

- 3. Administration of thiazolidinediones for more than three consecutive or a total of
seven non-consecutive days during the six weeks prior to screening.

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 2/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Local Institution - Wollongong
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Local Institution - Fullerton
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Local Institution - Box Hill
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Local Institution - Fitzroy
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Local Institution - Melbourne
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Local Institution - Parkville
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Local Institution - Perth
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- Wollongong
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- Fullerton
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- Box Hill
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- Fitzroy
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- Melbourne
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- Parkville
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- Perth
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Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the
Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes
Trial website
https://clinicaltrials.gov/show/NCT00240383
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Summary results
Other publications