Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106808
• Other study ID #: CV168-062
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2005
• Last updated: September 10, 2010
• Start date: August 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Muraglitazar

• Pioglitazone

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Chacabuco	Chaco
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Corrientes
Argentina	Local Institution	Santa Fe
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Broadmeadow	New South Wales
Australia	Local Institution	Cairns	Queensland
Australia	Local Institution	Concord	New South Wales
Australia	Local Institution	Daw Park	South Australia
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Freemantle	Western Australia
Australia	Local Institution	Geelong	Victoria
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Randwick	New South Wales
Australia	Local Institution	Westmead	New South Wales
Brazil	Local Institution	B. Rodolfo Teofilo	Ceara
Brazil	Local Institution	Bandeirantes	Sao Paulo
Brazil	Local Institution	Cerq. Cesar	Sao Paulo
Brazil	Local Institution	Guama	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Rua Maestro	Sao Paulo
Brazil	Local Institution	Ruo Maestro Cardim	Sao Paulo
Brazil	Local Institution	Vila Mariana	Sao Paulo
Canada	Local Institution	Antigonish	Nova Scotia
Canada	Local Institution	Cambridge	Ontario
Canada	Local Institution	Coquitlam	British Columbia
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Kitchener	Ontario
Canada	Local Institution	Langley	British Columbia
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	London	Ontario
Canada	Local Institution	Longueuil	Quebec
Canada	Local Institution	Markham	Ontario
Canada	Local Institution	North Bay	Ontario
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
Canada	Local Institution	Windsor	Ontario
Chile	Local Institution	Santiago	Valparaiso
India	Local Institution	Bangalore
India	Local Institution	Calcutta
India	Local Institution	Chennai
India	Local Institution	Hyderabad
India	Local Institution	Mumbai
India	Local Institution	New Delhi
India	Local Institution	Vellore
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico D.F.	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Morelia	Michioacan
Mexico	Local Institution	Zapopan	Jalisco
Peru	Local Institution	Lima
Peru	Local Institution	Lima 1
Philippines	Local Institution	Cebu
Philippines	Local Institution	Las Pinas
Philippines	Local Institution	Manila
Philippines	Local Institution	Manila City
Philippines	Local Institution	Pasig City
Philippines	Local Institution	Quezon
Philippines	Local Institution	Quezon City
Russian Federation	Local Institution	Kirov
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	Yaroslavl
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan Hsien
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Kong Kaen
Thailand	Local Institution	Songkla
Thailand	Local Institution	Taipei City
Ukraine	Local Institution	Dniepropetrovsk
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kiev
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Simferopol
United States	Local Institution	Atlanta	Georgia
United States	Local Institution	Austin	Texas
United States	Local Institution	Baltimore	Maryland
United States	Local Institution	Barberton	Ohio
United States	Local Institution	Bellbrook	Ohio
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Binghamton	New York
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Blue Ridge	Georgia
United States	Local Institution	Bountiful	Utah
United States	Local Institution	Boynton Beach	Florida
United States	Local Institution	Bridgewater	New Jersey
United States	Local Institution	Butte	Montana
United States	Local Institution	Cadillac	Michigan
United States	Local Institution	Calhoun	Georgia
United States	Local Institution	Canal Fulton	Ohio
United States	Local Institution	Canfield	Ohio
United States	Local Institution	Canton	Ohio
United States	Local Institution	Cantonville	Maryland
United States	Local Institution	Carrollton	Georgia
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Charlotte Harbour	Florida
United States	Local Institution	Chattanooga	Tennessee
United States	Local Institution	Cherry Hill	New Jersey
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Chipley	Florida
United States	Local Institution	Colorado Springs	Colorado
United States	Local Institution	Columbiana	Alabama
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Concord	California
United States	Local Institution	Corpus Christi	Texas
United States	Local Institution	Destin	Florida
United States	Local Institution	Dunwoody	Georgia
United States	Local Institution	East Providence	Rhode Island
United States	Local Institution	Encinitas	California
United States	Local Institution	Eugene	Oregon
United States	Local Institution	Evansville	Indiana
United States	Local Institution	Excelsior Springs	Missouri
United States	Local Institution	Falls Church	Virginia
United States	Local Institution	Fayetteville	Tennessee
United States	Local Institution	Fresno	California
United States	Local Institution	Glendale	Arizona
United States	Local Institution	Greenville	North Carolina
United States	Local Institution	Greer	South Carolina
United States	Local Institution	Gulfport	Mississippi
United States	Local Institution	Hickory	North Carolina
United States	Local Institution	Holly Hill	Florida
United States	Local Institution	Houston	Texas
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Irving	Texas
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Johnson City	New York
United States	Local Institution	La Jolla	California
United States	Local Institution	Lafayette	Louisiana
United States	Local Institution	Los Angeles	California
United States	Local Institution	Los Gatos	California
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Lyndhurst	Ohio
United States	Local Institution	Madison	Alabama
United States	Local Institution	Marietta	Georgia
United States	Local Institution	Medford	Oregon
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Mentor	Ohio
United States	Local Institution	Mesa	Arizona
United States	Local Institution	Miami	Florida
United States	Local Institution	Midland	Texas
United States	Local Institution	Mineola	New York
United States	Local Institution	Missoula	Montana
United States	Local Institution	Morehead City	North Carolina
United States	Local Institution	Mount Pleasant	South Carolina
United States	Local Institution	New Braunfels	Texas
United States	Local Institution	New Port Richey	Florida
United States	Local Institution	Niceville	Florida
United States	Local Institution	Norfolk	Virginia
United States	Local Institution	North Chicago	Illinois
United States	Local Institution	Northport	New York
United States	Local Institution	Orange	California
United States	Local Institution	Panama City	Florida
United States	Local Institution	Pasadena	California
United States	Local Institution	Pearland	Texas
United States	Local Institution	Peoria	Arizona
United States	Local Institution	Philipsburg	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Port Charlotte	Florida
United States	Local Institution	Portage	Michigan
United States	Local Institution	Portland	Oregon
United States	Local Institution	Reading	Pennsylvania
United States	Local Institution	Richland	Michigan
United States	Local Institution	Rosenberg	Texas
United States	Local Institution	Roseville	California
United States	Local Institution	Salem	Virginia
United States	Local Institution	Salisbury	North Carolina
United States	Local Institution	San Antonio	Texas
United States	Local Institution	Santa Monica	California
United States	Local Institution	Scottsdale	Arizona
United States	Local Institution	Selmer	Tennessee
United States	Local Institution	Shawnee Mission	Kansas
United States	Local Institution	Shreveport	Louisiana
United States	Local Institution	Simpsonville	South Carolina
United States	Local Institution	Spokane	Washington
United States	Local Institution	St. Peters	Missouri
United States	Local Institution	Swansea	Massachusetts
United States	Local Institution	Tipton	Pennsylvania
United States	Local Institution	Towson	Maryland
United States	Local Institution	Tupelo	Mississippi
United States	Local Institution	West Grove	Pennsylvania
United States	Local Institution	Westminister	Maryland
United States	Local Institution	Wichita	Kansas
United States	Local Institution	Wilmington	Delaware
United States	Local Institution	Wilmington	North Carolina
United States	Local Institution	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  India,  Mexico,  Peru,  Philippines,  Russian Federation,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBA1c from baseline to Week 24
Secondary	Change for baseline in TG and HDL-C at Week 24
Secondary	Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.
Secondary	To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm