A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
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
1 other identifier
interventional
341
7 countries
130
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2003
Shorter than P25 for phase_3
130 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 1, 2005
CompletedApril 27, 2012
April 1, 2012
October 28, 2005
April 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline to Week 24
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with Type 2 diabetes
- Drug Naive
- HbA1c \>= 7.0% and \<= 10.0%
- Body Mass Index \<= 41 kg/m2
- Serum TG \<= 600 mg/dL
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (130)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Haleyville, Alabama, United States
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Hoover, Alabama, United States
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Fayetteville, Arizona, United States
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Hot Springs, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tulsa, Arizona, United States
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Concord, California, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Los Gatos, California, United States
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Raleigh, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Colorado Springs, Colorado, United States
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Golden, Colorado, United States
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Littleton, Colorado, United States
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New Britain, Connecticut, United States
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Altamonte Springs, Florida, United States
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Brandon, Florida, United States
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Chipley, Florida, United States
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Coral Gables, Florida, United States
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Kissimmee, Florida, United States
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Longwood, Florida, United States
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Melbourne, Florida, United States
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New Port Richie, Florida, United States
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Ocala, Florida, United States
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Pinellas Park, Florida, United States
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Chicago, Illinois, United States
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Overland Park, Kansas, United States
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Shawnee Mission, Kansas, United States
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Lexington, Kentucky, United States
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Madisonville, Kentucky, United States
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Shreveport, Louisiana, United States
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Gulfport, Mississippi, United States
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Saint Peters, Mississippi, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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Elizabeth, New Jersey, United States
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Toms River, New Jersey, United States
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Endwell, New York, United States
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West Seneca, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Morehead City, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Franklin, Ohio, United States
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Newark, Ohio, United States
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Zanesville, Ohio, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Johnston, Rhode Island, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Fort Worth, Texas, United States
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Lubbock, Texas, United States
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San Angelo, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Edmonds, Washington, United States
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Federal Way, Washington, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Milwaukee, Wisconsin, United States
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Canberra, New South Wales, Australia
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Sydney, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Kippa-Ring, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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Launceston, Tasmania, Australia
Tasmania
Melbourne, Victoria, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Manuels, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Thornhill, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Chicoutimi, Quebec, Canada
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Drummondville, Quebec, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Aguascalientes, Aguascalientes, Mexico
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Durango, Durango, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Krakow, Poland
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Lodz, Poland
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Mroków, Poland
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Warsaw, Poland
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Zabrze, Poland
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Añasco, Puerto Rico
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Ponce, Puerto Rico
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Rio Pieoras, Puerto Rico
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Changhua, Taiwan
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Taichung, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 28, 2005
First Posted
November 1, 2005
Study Start
June 1, 2003
Study Completion
April 1, 2004
Last Updated
April 27, 2012
Record last verified: 2012-04