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/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
Gender
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
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,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
Recruitment hospital [9] 0 0
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
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Cairns
Recruitment postcode(s) [7] 0 0
- Daw Park
Recruitment postcode(s) [8] 0 0
- Box Hill
Recruitment postcode(s) [9] 0 0
- Fitzroy
Recruitment postcode(s) [10] 0 0
- Geelong
Recruitment postcode(s) [11] 0 0
- Melbourne
Recruitment postcode(s) [12] 0 0
- Freemantle
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
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Chaco
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Corrientes
Country [36] 0 0
Argentina
State/province [36] 0 0
Santa Fe
Country [37] 0 0
Brazil
State/province [37] 0 0
Ceara
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio Grande Do Sul
Country [39] 0 0
Brazil
State/province [39] 0 0
Sao Paulo
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Valparaiso
Country [46] 0 0
India
State/province [46] 0 0
Bangalore
Country [47] 0 0
India
State/province [47] 0 0
Calcutta
Country [48] 0 0
India
State/province [48] 0 0
Chennai
Country [49] 0 0
India
State/province [49] 0 0
Hyderabad
Country [50] 0 0
India
State/province [50] 0 0
Mumbai
Country [51] 0 0
India
State/province [51] 0 0
New Delhi
Country [52] 0 0
India
State/province [52] 0 0
Vellore
Country [53] 0 0
Mexico
State/province [53] 0 0
Distrito Federal
Country [54] 0 0
Mexico
State/province [54] 0 0
Jalisco
Country [55] 0 0
Mexico
State/province [55] 0 0
Michioacan
Country [56] 0 0
Mexico
State/province [56] 0 0
Nuevo Leon
Country [57] 0 0
Mexico
State/province [57] 0 0
Aguascalientes
Country [58] 0 0
Mexico
State/province [58] 0 0
Chihuahua
Country [59] 0 0
Peru
State/province [59] 0 0
Lima 1
Country [60] 0 0
Peru
State/province [60] 0 0
Lima
Country [61] 0 0
Philippines
State/province [61] 0 0
Cebu
Country [62] 0 0
Philippines
State/province [62] 0 0
Las Pinas
Country [63] 0 0
Philippines
State/province [63] 0 0
Manila City
Country [64] 0 0
Philippines
State/province [64] 0 0
Manila
Country [65] 0 0
Philippines
State/province [65] 0 0
Pasig City
Country [66] 0 0
Philippines
State/province [66] 0 0
Quezon City
Country [67] 0 0
Philippines
State/province [67] 0 0
Quezon
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Kirov
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Saratov
Country [71] 0 0
Russian Federation
State/province [71] 0 0
St. Petersburg
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Yaroslavl
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taipei
Country [75] 0 0
Taiwan
State/province [75] 0 0
Taoyuan Hsien
Country [76] 0 0
Thailand
State/province [76] 0 0
Bangkok
Country [77] 0 0
Thailand
State/province [77] 0 0
Kong Kaen
Country [78] 0 0
Thailand
State/province [78] 0 0
Songkla
Country [79] 0 0
Thailand
State/province [79] 0 0
Taipei City
Country [80] 0 0
Ukraine
State/province [80] 0 0
Dniepropetrovsk
Country [81] 0 0
Ukraine
State/province [81] 0 0
Kharkiv
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kiev
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kyiv
Country [84] 0 0
Ukraine
State/province [84] 0 0
Odessa
Country [85] 0 0
Ukraine
State/province [85] 0 0
Simferopol

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 Corp.
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/show/NCT00106808
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
Other publications