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

April 26, 2012 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

341

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in HbA1c from baseline to Week 24

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV168-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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