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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
341

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Change in HbA1c from baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings