A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

April 14, 2015 updated by: AstraZeneca

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

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.
768

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

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Local Institution
      • Buenos Aires, Argentina, C1406FEQ
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
    • Buenos Aires
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
  • Brazil
    • Ceara
      • B. Rodolfo Teofilo, Ceara, Brazil, 60430
        • Local Institution
      • Fortaleza, Ceara, Brazil, 60021
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150
        • Local Institution
    • Para
      • Belem, Para, Brazil, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
        • Local Institution
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13059
        • Local Institution
      • Marília, Sao Paulo, Brazil, 17519
        • Local Institution
      • Sao Paulo - Sp, Sao Paulo, Brazil, 04231
        • Local Institution
      • Vila Mariana, Sao Paulo, Brazil, 04020
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong, SAR
        • Local Institution
      • Kowloon, Hong Kong
        • Local Institution
  • Israel
      • Givatayim, Israel, 53583
        • Local Institution
      • Haifa, Israel, 31096
        • Local Institution
      • Holon, Israel, 58100
        • Local Institution
      • Jerusalem, Israel, 91120
        • Local Institution
      • Rishon Le-Zion, Israel, 75650
        • Local Institution
      • Tel Aviv, Israel, 64353
        • Local Institution
      • Zefat, Israel, 13100
        • Local Institution
      • Zerifin, Israel, 70300
        • Local Institution
  • Korea, Republic of
      • Kyunggi-Do, Korea, Republic of, 420-717
        • Local Institution
      • Kyunggi-Do, Korea, Republic of, 463-707
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 135-720
        • Local Institution
      • Seoul, Korea, Republic of, 137040
        • Local Institution
      • Seoul, Korea, Republic of, 130-702
        • Local Institution
      • Suwon, Korea, Republic of, 443721
        • Local Institution
  • Mexico
      • Durango, Mexico, 64710
        • Local Institution
    • Baja California
      • Tijuana, B.C., Baja California, Mexico, 22320
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexico, 11800
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44340
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97210
        • Local Institution
  • Peru
      • Lima, Peru, LIMA 31
        • Local Institution
      • Lima, Peru, 18
        • Local Institution
      • Lima, Peru, LIMA 1
        • Local Institution
    • Lima
      • San Isidro, Lima, Peru, 27
        • Local Institution
  • Philippines
      • Cebu, Philippines, 6000
        • Local Institution
      • Manila, Philippines, 1000
        • Local Institution
      • Quezon, Philippines, 1102
        • Local Institution
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Local Institution
      • Guaynabo, Puerto Rico, 00966
        • Local Institution
      • Ponce, Puerto Rico, 00716
        • Local Institution
      • Ponce, Puerto Rico, 00717
        • Local Institution
  • Singapore
      • Singapore, Singapore, 119074
        • Local Institution
  • South Africa
      • Cape Town, South Africa, 7008
        • Local Institution
      • Johannesburg, South Africa, 2196
        • Local Institution
    • Kwa Zulu Natal
      • Umhlanga Rocks, Kwa Zulu Natal, South Africa, 4319
        • Local Institution
    • Northern Cape
      • Kimberley, Northern Cape, South Africa, 8301
        • Local Institution
    • Western Cape
      • Tygerberg, Western Cape, South Africa, 7505
        • Local Institution
  • Taiwan
      • Changhua, Taiwan, 500
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Reserach Solutions, Llc
      • Searcy, Arkansas, United States, 72143
        • Searcy Medical Center
    • California
      • Alhambra, California, United States, 91801
        • Stewart Medical Group
      • Fountain Valley, California, United States, 92708
        • Southland Clinical Research Center, Inc.
      • Fresno, California, United States, 93720
        • Valley Research
      • Los Angeles, California, United States, 90023
        • Randall Shue, D.O.
      • Roseville, California, United States, 95661
        • Clinical Trials Research
    • Colorado
      • Golden, Colorado, United States, 80401
        • New West Physicians
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Phoenix Internal Medicine Associates, Llc
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Research Institute
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Central Florida Clinical Trials
      • Chipley, Florida, United States, 32428
        • Family Care Assoc & Emerald Care Res Grp
      • Coral Gables, Florida, United States, 33134
        • Clinical Therapeutics Corporation
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Marianna, Florida, United States, 32446
        • Emerald Coast Research Group
      • Miami, Florida, United States, 33136
        • University Of Miami Diabetes Research Inst.
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Pharmaceutical Research Center, Inc
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Ctr
    • Kentucky
      • Munfordville, Kentucky, United States, 42765
        • Family Medical Center Of Hart Co.
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Columbia Medical Practice
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • VA Medical Center
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Nevada Alliance Against Diabetes
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Physicians Research Center
    • New York
      • East Syracuse, New York, United States, 13057
        • Cny Family Care
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine
      • Charlotte, North Carolina, United States, 28211
        • Med Res Assoc Charlotte
      • High Point, North Carolina, United States, 27262
        • Regional Physicians Research
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endocrinology Consultants, PC
      • Sparta, North Carolina, United States, 28675
        • Mountain Top Clinical Research Center
    • Ohio
      • Akron, Ohio, United States, 44313
        • DayStar Clinical Research, Inc.
      • Canal Fulton, Ohio, United States, 44614
        • Community Health care
      • Franklin, Ohio, United States, 45005
        • Triphase Research, Ltd.
      • Mason, Ohio, United States, 45040
        • Albert J Weisbrot,Md&Assoc Inc
      • Youngstown, Ohio, United States, 44507
        • Dr Bahagwan Dass Md
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73132
        • Oklahoma Cardiovascular and Hypertension Center
      • Tulsa, Oklahoma, United States, 74104
        • Utica Park Clinic
      • Yukon, Oklahoma, United States, 73109
        • Integris Family Care Yukon
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Coordinators Plus, Llc
      • Portland, Oregon, United States, 97220
        • Oregon Clinical Research
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Pearl Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15216
        • Banksville Medical Pc
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd
    • South Carolina
      • Simsonville, South Carolina, United States, 29681
        • Upstate Pharmaceutical Research
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
      • Taylors, South Carolina, United States, 29687
        • Southeastern Research Assoc
    • Texas
      • Austin, Texas, United States, 78705
        • Capital Medical Clinic, Llp
      • Houston, Texas, United States, 77081
        • Texas Center For Drug Development, P.A.
      • Katy, Texas, United States, 77450
        • Breath of Life Research Institute
      • San Antonio, Texas, United States, 78229
        • S.A.M. Clinical Research Center
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Research Assoc, Pa
    • Virginia
      • Virginia Beach, Virginia, United States, 23451
        • Tidewater Integrated Medical Research
    • Washington
      • Spokane, Washington, United States, 99216
        • Office Of Dr. Gray
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare S.C.

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.
  • Treated with a sulfonylurea for at least 2 months.
  • Inadequate blood sugar control.
  • Are not on any other medications to lower blood sugar.
  • No major heart, liver or kidney problems.
  • Women not pregnant or breast feeding.

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 + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Other Names:
  • BMS-477118
Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Drug: Glyburide
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
Other Names:
  • BMS-477118
Drug: Saxagliptin
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Other Names:
  • BMS-477118
Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Drug: Glyburide
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Placebo Comparator: Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Drug: Glyburide
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Drug: Placebo
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks 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 A1c (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 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 plus glyburide versus placebo plus upward titrated glyburide 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 values.
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.
April 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.
September 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.
September 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 10, 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 11, 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 12, 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.
May 4, 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 14, 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.
  • CV181-040

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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