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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/NCT00106808




Registration number
NCT00106808
Ethics application status
Date submitted
31/03/2005
Date registered
1/04/2005
Date last updated
14/09/2010

Titles & IDs
Public title
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Scientific title
A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Secondary ID [1] 0 0
CV168-062
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 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
Treatment: Drugs - Muraglitazar
Treatment: Drugs - Pioglitazone

Treatment: Drugs: Muraglitazar


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

Outcomes
Primary outcome [1] 0 0
Change in HBA1c from baseline to Week 24
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change for baseline in TG and HDL-C at Week 24
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Type 2 Diabetes

- HbA1c > = 8.0% and < = 12.0%

- Serum triglyceride concentration < = 600 mg/dL

- Fasting c-peptide > = 1.0 ng/ml

- Body mass index < = 41 kg/m2

- Drug naive patients
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 accidents, accelerated/malignant hypertension, or hypertension related
CHF (congestive heart failure) within six months prior to screening and during the
Lead-In Phase.

- Women of child Bearing Potential

- Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II,
III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled
cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.

- History of renal disease, bladder cancer, 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
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Broadmeadow
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Randwick
Recruitment hospital [4] 0 0
Local Institution - Westmead
Recruitment hospital [5] 0 0
Local Institution - Brisbane
Recruitment hospital [6] 0 0
Local Institution - Cairns
Recruitment hospital [7] 0 0
Local Institution - Daw Park
Recruitment hospital [8] 0 0
Local Institution - Box Hill
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Local Institution - Fitzroy
Recruitment hospital [10] 0 0
Local Institution - Geelong
Recruitment hospital [11] 0 0
Local Institution - Melbourne
Recruitment hospital [12] 0 0
Local Institution - Freemantle
Recruitment postcode(s) [1] 0 0
- Broadmeadow
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- Concord
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- Randwick
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- Westmead
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- Brisbane
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- Cairns
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- Daw Park
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- Box Hill
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- Fitzroy
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- Geelong
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- Melbourne
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- Freemantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2
Diabetes. Both the safety and blood sugar lowering effects of these treatments will be
studied.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00106808
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00106808