A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

November 16, 2016 updated by: AstraZeneca

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

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 (Actual)

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.
389

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 2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Local Institution
      • Edmonton, Alberta, Canada
        • Local Institution
    • British Columbia
      • Langley, British Columbia, Canada
        • Local Institution
      • Surrey, British Columbia, Canada
        • Local Institution
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Canada
        • Local Institution
      • Moncton, New Brunswick, Canada
        • Local Institution
      • St. John's, New Brunswick, Canada
        • Local Institution
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Local Institution
    • Ontario
      • Corunna, Ontario, Canada
        • Local Institution
      • Etobicoke, Ontario, Canada
        • Local Institution
      • Kitchener, Ontario, Canada
        • Local Institution
      • Newmarket, Ontario, Canada
        • Local Institution
      • Sarnia, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Canada
        • Local Institution
      • Granby, Quebec, Canada
        • Local Institution
      • Greenfield Park, Quebec, Canada
        • Local Institution
      • Rimouski, Quebec, Canada
        • Local Institution
      • St-Leonard, Quebec, Canada
        • Local Institution
      • Ste-Foy, Quebec, Canada
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico
        • Local Institution
      • Durango, Mexico
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Local Institution
      • Zapopan, Jalisco, Mexico
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Local Institution
  • Puerto Rico
      • Caguas, Puerto Rico
        • Local Institution
      • Manati, Puerto Rico
        • Local Institution
      • San Juan, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Bayou La Batre, Alabama, United States
        • Local Institution
      • Birmingham, Alabama, United States
        • Local Institution
      • Huntsville, Alabama, United States
        • Local Institution
      • Mobile, Alabama, United States
        • Local Institution
    • Arizona
      • Chandler, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • Arkansas
      • Fayetteville, Arkansas, United States
        • Local Institution
      • Hot Springs, Arkansas, United States
        • Local Institution
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Los Gatos, California, United States
        • Local Institution
      • Mission Viejo, California, United States
        • Local Institution
      • Orange, California, United States
        • Local Institution
      • Redondo Beach, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Torrance, California, United States
        • Local Institution
    • Colorado
      • Colorado Springs, Colorado, United States
        • Local Institution
      • Denver, Colorado, United States
        • Local Institution
    • Florida
      • Boynton Beach, Florida, United States
        • Local Institution
      • Brandon, Florida, United States
        • Local Institution
      • Delray Beach, Florida, United States
        • Local Institution
      • Holly Hill, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Instiuttion
      • New Port Richey, Florida, United States
        • Local Institution
      • Orlando, Florida, United States
        • Local Institution
      • Ormond Beach, Florida, United States
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    • Georgia
      • Augusta, Georgia, United States
        • Local Institution
      • Blue Ridge, Georgia, United States
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
      • Lafayette, Indiana, United States
        • Local Institution
    • Kansas
      • Arkansas City, Kansas, United States
        • Local Institution
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Local Institution
    • Maryland
      • Columbia, Maryland, United States
        • Local Institution
      • Elkton, Maryland, United States
        • Local Institution
    • Massachusetts
      • Sudbury, Massachusetts, United States
        • Local Institution
      • Worcester, Massachusetts, United States
        • Local Institution
    • Michigan
      • Dearborn, Michigan, United States
        • Local Institution
      • Royal Oak, Michigan, United States
        • Local Institution
    • Minnesota
      • Brooklyn Center, Minnesota, United States
        • Local Institution
      • Edina, Minnesota, United States
        • Local Insitution
      • Minneapolis, Minnesota, United States
        • Local Institution
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Local Institution
      • Jackson, Mississippi, United States
        • Local Institution
    • Missouri
      • Chesterfield, Missouri, United States
        • Local Institution
      • Kansas City, Missouri, United States
        • Local Institution
      • St. Louis, Missouri, United States
        • Local Institution
    • Nebraska
      • Scottsbluff, Nebraska, United States
        • Local Institution
    • Nevada
      • North Las Vegas, Nevada, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
      • Alburquerque, New Mexico, United States
        • Local Institution
      • Los Alamos, New Mexico, United States
        • Local Institution
    • New York
      • Albany, New York, United States
        • Local Institution
      • Bronxville, New York, United States
        • Local Institution
      • Camillus, New York, United States
        • Local Institution
      • Cooperstown, New York, United States
        • Local Institution
      • New Hyde Park, New York, United States
        • Local Instiution
      • 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
      • Raleigh, North Carolina, United States
        • Local Institution
      • Wilmington, North Carolina, United States
        • Local Institution
    • Ohio
      • Akron, Ohio, United States
        • Local Institution
      • Beachwood, Ohio, United States
        • Local Institution
      • Cincinnati, Ohio, United States
        • Local Institution
      • Cleveland, Ohio, United States
        • Local Institution
      • Dayton, Ohio, United States
        • Local Institution
      • Mogadore, Ohio, United States
        • Local Institution
      • Newark, Ohio, United States
        • Local Institution
      • Zanesville, Ohio, United States
        • Local Institution
    • Oklahoma
      • Bethany, Oklahoma, United States
        • Local Institution
      • Yukon, Oklahoma, United States
        • Local Institution
    • Oregon
      • Bend, Oregon, United States
        • Local Institution
      • Eugene, Oregon, United States
        • Local Institution
      • Hillsboro, Oregon, United States
        • Local Institution
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
        • Local Institution
      • Feasterville, Pennsylvania, United States
        • Local Institution
      • Levittown, Pennsylvania, United States
        • Local Institution
      • Morrisville, Pennsylvania, United States
        • Local Institution
      • Reading, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Cumberland, Rhode Island, United States
        • Local Institution
      • Johnston, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Anderson, South Carolina, United States
        • Local Institution
      • Simpsonville, South Carolina, United States
        • Local Institution
      • Summerville, South Carolina, United States
        • Local Institution
      • Taylors, South Carolina, United States
        • Local Institution
    • South Dakota
      • Rapid City, South Dakota, United States
        • Local Institution
    • Tennessee
      • Memphis, Tennessee, United States
        • Local Institution
      • Nashville, Tennessee, United States
        • Local Institution
      • Selmer, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Bellaire, Texas, United States
        • Local Institution
      • Bryan, Texas, United States
        • Local Institution
      • El Paso, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
      • Irving, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States
        • Local Institution
    • Virginia
      • Burke, Virginia, United States
        • Local Institution
      • Hampton, Virginia, United States
        • Local Institution
      • Norfolk, Virginia, United States
        • Local Institution
      • Richmond, Virginia, United States
        • Local Institution
      • Virginia Beach, Virginia, United States
        • Local Institution
    • Washington
      • Edmonds, Washington, United States
        • Local Institution
      • Renton, Washington, United States
        • Local Institution
      • Spokane, Washington, United States
        • Local Institution
      • Vancouver, Washington, United States
        • Local Institution
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Local Institution
      • West Allis, 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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
  • Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
  • C-peptide > 1.0 ng/ml
  • Body Mass Index <= 40 kg/m2
  • Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
  • No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Exclusion Criteria:

  • Unstable renal disease
  • Patients with significant liver disease including chronic active hepatitis
  • Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
  • Subjects with clinically significant anemia

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Arm 1
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Experimental: Arm 2
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Experimental: Arm 3
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Experimental: Arm 4
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Experimental: Arm 5
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Placebo Comparator: Arm 6
Drug: placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks.
Active Comparator: Arm 7
Drug: metformin
Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

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
Time Frame
Mean change from baseline in HbA1c compared to placebo.
Time Frame: at 12 weeks
at 12 weeks

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
Time Frame
Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion
Time Frame: at Weeks 6 and 12
at Weeks 6 and 12

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.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
December 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2007

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.
February 1, 2007

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).
December 7, 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.
December 7, 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.
December 8, 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.
November 17, 2016

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.
November 16, 2016

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.
November 1, 2016

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.
  • MB102-008

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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