Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

April 8, 2015 updated by: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with 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.

Detailed Description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

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.
365

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

  • India
      • Bangalore, India, 560034
        • Local Institution
      • Mumbai, India, 400007
        • Local Institution
      • Mumbai, India, 400021
        • Local Institution
      • Nagpur, India, 440012
        • Local Institution
    • Karnataka
      • Manipal, Karnataka, India, 576104
        • Local Institution
    • Kerala
      • Kochi, Kerala, India, 682026
        • Local Institution
    • Mangalore
      • Attavar, Mangalore, India, 575001
        • Local Institution
    • New Delhi
      • Sarita Vihar, New Delhi, India, 110076
        • Local Institution
  • Russian Federation
      • Moscov, Russian Federation, 118089
        • Local Institution
      • Moscow, Russian Federation, 115487
        • Local Institution
      • Nizhniy Novgorod, Russian Federation, 603126
        • Local Institution
      • Saint Petersburg, Russian Federation, 198013
        • Local Institution
      • Saratov, Russian Federation, 410018
        • Local Institution
      • Saratov, Russian Federation, 410054
        • Local Institution
      • Smolensk, Russian Federation, 214018
        • Local Institution
      • St.Petersburg, Russian Federation, 194156
        • Local Institution
      • Volgograd, Russian Federation, 400138
        • Local Institution
  • Taiwan
      • Changhua, Taiwan, 500
        • Local Institution
      • Kaohsiung County, Taiwan, 833
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Taichung City, Taiwan, 407
        • Local Institution
      • Taipei City, Taiwan, 114
        • Local Institution
      • Tao-Yuan County, Taiwan, 333
        • Local Institution
  • United States
    • Alabama
      • Columbiana, Alabama, United States, 35051
        • Tomac, Inc.
      • Haleyville, Alabama, United States, 35565
        • Winston Technology, Inc.
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Clinical Reseacrh Advantage/ Brown Family Medicine
    • California
      • Bakersfield, California, United States, 93311
        • Strategos Medical Group
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Cudahy, California, United States, 90201
        • Rx for Life, Inc
      • Encino, California, United States, 91436
        • Medical Group of Encino
      • Fountain Valley, California, United States, 92708
        • Southland Clinical Research Center, Inc.
      • Fresno, California, United States, 93720
        • Valley Research
      • Northridge, California, United States, 91325
        • Diabetes Medical Center Of California
      • Pico Rivera, California, United States, 90660
        • In Private Prictice Clinic
      • San Jose, California, United States, 95128
        • San Jose Clinical Research, Inc.
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Central Florida Clinical Trials, Inc.
      • Melbourne, Florida, United States, 32935
        • Accelovance
      • Sarasota, Florida, United States, 34243
        • University Family Healthcare, Pa
      • St. Petersburg, Florida, United States, 33707
        • Premier Healthcare
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Pinnacle Medical Research
    • Missouri
      • Kansas City, Missouri, United States, 64106
        • Kansas City University Of Medicine And Biosciences
      • Wentzville, Missouri, United States, 63385
        • Primary Care Physicians, Pc
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Physicians Research Center
    • New York
      • Kingston, New York, United States, 12401
        • Hudson Valley Clinical Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Neem Research Group of Charlotte
      • Greenville, North Carolina, United States, 27834
        • Diabetes Center- East Carolina University
      • Salisbury, North Carolina, United States, 28144
        • Crescent Medical Research
    • Ohio
      • Barberton, Ohio, United States, 44203
        • Community Health Care, Inc.
      • Canton, Ohio, United States, 44718
        • Clinical Research Limited
      • Kettering, Ohio, United States, 45429
        • Wells Institute for Health Awareness
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Accelovance
      • Oklahoma City, Oklahoma, United States, 73170
        • Integris Family Care South
    • Oregon
      • Eugene, Oregon, United States, 97404
        • The Office Of Patricia Buchanan
    • Pennsylvania
      • Carlisle, Pennsylvania, United States, 17015
        • Cumberland Valley Endocrinology Center, Llc
      • Fleetwood, Pennsylvania, United States, 19522
        • Fleetwood Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15216
        • Banksville Medical, Pc
      • Shippensburg, Pennsylvania, United States, 17257
        • Biomedical Research Associates, Llc
    • South Carolina
      • Duncan, South Carolina, United States, 29334
        • Middle Tyger Family Medicine
      • Taylors, South Carolina, United States, 29687
        • Southeastern Research Assoc
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
        • Versoza & Ungab Internal Medicine Associates
      • Collierville, Tennessee, United States, 38017
        • Collierville Medical Specialist
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38116
        • Med-South Research
      • Memphis, Tennessee, United States, 38125
        • Southwind Medical Specialist
    • Texas
      • Carrollton, Texas, United States, 75010
        • Precision Family Medicine
      • Corpus Christi, Texas, United States, 78411
        • Alpha Therapy Research Center
      • Houston, Texas, United States, 77081
        • Texas Center For Drug Development, P.A.
      • Houston, Texas, United States, 77024
        • Village Family Practice
      • San Antonio, Texas, United States, 78224
        • Abbott Clinical Research Group, Inc
    • Utah
      • Bountiful, Utah, United States, 84010
        • Taylor/Wade Medical
      • Salt Lake City, Utah, United States, 84102
        • Optimum Clinical Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23451
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, United States, 99216
        • Spokane Internal Medicine

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 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Inadequate blood sugar control

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding

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: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Names:
  • BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Placebo Comparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Drug: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)

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
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Time Frame: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, 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
Measure Description
Time Frame
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Time Frame: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline, Week 24
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
Time Frame: Week 24
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Time Frame: Baseline, Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Baseline, Week 24

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

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

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, 2006

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.
November 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.
November 1, 2008

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).
April 18, 2006

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.
April 19, 2006

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.
April 20, 2006

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 29, 2015

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 8, 2015

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.
March 1, 2015

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.
  • CV181-038

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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