A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Diabetes, Type 2 Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246987
• Other study ID #: CV168-018
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2005
• Last updated: April 26, 2012
• Start date: June 2003
• Est. completion date: April 2004

Study information

• Verified date: April 2012
• 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

To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects with Type 2 diabetes

• Drug Naive

• HbA1c >= 7.0% and <= 10.0%

• Body Mass Index <= 41 kg/m2

• Serum TG <= 600 mg/dL

Exclusion Criteria:

• Symptomatic Type 2 diabetes

• History of bladder cancer

• History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), 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
• Diabetes, Type 2

Intervention

Drug:
• Muraglitazar

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Canberra	New South Wales
Australia	Local Institution	Kippa Ring	Queensland
Australia	Local Institution	Launceston	Tasmania
Australia	Local Institution	Meadowbrook	Queensland
Australia	Tasmania	Melbourne	Victoria
Australia	Local Institution	Sydney	New South Wales
Australia	Local Institution	Wollongong	New South Wales
Australia	Local Institution	Woodville	South Australia
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Charlottetown	Prince Edward Island
Canada	Local Institution	Chicoutimi	Quebec
Canada	Local Institution	Coquitlam	British Columbia
Canada	Local Institution	Drummondville	Quebec
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Granby	Quebec
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	Longueuil	Quebec
Canada	Local Institution	Manuels	Newfoundland and Labrador
Canada	Local Institution	Markham	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Oakville	Ontario
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Pointe-Claire	Quebec
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	St-Lambert	Quebec
Canada	Local Institution	St. John's	Newfoundland and Labrador
Canada	Local Institution	Ste-Foy	Quebec
Canada	Local Institution	Thornhill	Ontario
Canada	Local Institution	Thunder Bay	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Winnipeg	Manitoba
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	Durango
Mexico	Local Institution	Mexico City	Distrito Federal
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Mrokow
Poland	Local Institution	Warszawa
Poland	Local Institution	Zabrze
Puerto Rico	Local Institution	Anasco
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	Rio Pieoras
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Taichung
United States	Local Institution	Altamonte Springs	Florida
United States	Local Institution	Anderson	South Carolina
United States	Local Institution	Anniston	Alabama
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Brandon	Florida
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Chesterfield	Missouri
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Chipley	Florida
United States	Local Institution	Colorado Springs	Colorado
United States	Local Institution	Concord	California
United States	Local Institution	Coral Gables	Florida
United States	Local Institution	East Providence	Rhode Island
United States	Local Institution	Edmonds	Washington
United States	Local Institution	Elizabeth	New Jersey
United States	Local Institution	Endwell	New York
United States	Local Institution	Eugene	Oregon
United States	Local Institution	Fayetteville	Arizona
United States	Local Institution	Federal Way	Washington
United States	Local Institution	Fort Worth	Texas
United States	Local Institution	Fountain Valley	California
United States	Local Institution	Franklin	Ohio
United States	Local Institution	Golden	Colorado
United States	Local Institution	Greer	South Carolina
United States	Local Institution	Gulfport	Mississippi
United States	Local Institution	Haleyville	Alabama
United States	Local Institution	High Point	North Carolina
United States	Local Institution	Hoover	Alabama
United States	Local Institution	Hot Springs	Arizona
United States	Local Institution	Johnston	Rhode Island
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	Kissimmee	Florida
United States	Local Institution	Knoxville	Tennessee
United States	Local Institution	Lexington	Kentucky
United States	Local Institution	Littleton	Colorado
United States	Local Institution	Long Beach	California
United States	Local Institution	Longwood	Florida
United States	Local Institution	Los Gatos	California
United States	Local Institution	Lubbock	Texas
United States	Local Institution	Madisonville	Kentucky
United States	Local Institution	Melbourne	Florida
United States	Local Institution	Memphis	Tennessee
United States	Local Institution	Mesa	Arizona
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	Morehead City	North Carolina
United States	Local Institution	Mount Pleasant	South Carolina
United States	Local Institution	New Britain	Connecticut
United States	Local Institution	New Port Richie	Florida
United States	Local Institution	Newark	Ohio
United States	Local Institution	Ocala	Florida
United States	Local Institution	Olympia	Washington
United States	Local Institution	Overland Park	Kansas
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Pinellas Park	Florida
United States	Local Institution	Portland	Oregon
United States	Local Institution	Providence	Rhode Island
United States	Local Institution	Raleigh	California
United States	Local Institution	Reading	Pennsylvania
United States	Local Institution	Richmond	Virginia
United States	Local Institution	Roseville	California
United States	Local Institution	Salisbury	North Carolina
United States	Local Institution	Salt Lake City	Utah
United States	Local Institution	San Angelo	Texas
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Diego	California
United States	Local Institution	Shawnee Mission	Kansas
United States	Local Institution	Shreveport	Louisiana
United States	Local Institution	Spokane	Washington
United States	Local Institution	Spring Valley	California
United States	Local Institution	Springfield	Missouri
United States	Local Institution	St. Peters	Mississippi
United States	Local Institution	Toms River	New Jersey
United States	Local Institution	Tucson	Arizona
United States	Local Institution	Tulsa	Arizona
United States	Local Institution	Tustin	California
United States	Local Institution	Vancouver	Washington
United States	Local Institution	Virginia Beach	Virginia
United States	Local Institution	Warminster	Pennsylvania
United States	Local Institution	West Seneca	New York
United States	Local Institution	Winston Salem	North Carolina
United States	Local Institution	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Mexico,  Poland,  Puerto Rico,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to Week 24
Secondary	Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.

External Links

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