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

NCT ID: NCT00246987

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Muraglitazar

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

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

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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

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Countries

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United States Australia Canada Mexico Poland Puerto Rico Taiwan

Other Identifiers

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CV168-018

Identifier Type: -

Identifier Source: org_study_id

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