Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

March 29, 2017 updated by: AstraZeneca

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment 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.
1282

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

  • Canada
      • Quebec, Canada, G1N 4V3
        • Local Institution
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3P4
        • Local Institution
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Local Institution
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Local Institution
      • Toronto, Ontario, Canada, M9W 4L6
        • Local Institution
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Local Institution
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Incheon, Korea, Republic of, 405-760
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Seoul, Korea, Republic of, 110-774
        • Local Institution
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 420-717
        • Local Institution
      • Sungnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Local Institution
      • Chihuahua, Mexico, 31217
        • Local Institution
      • Durango, Mexico, 34000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
    • Morelos
      • Cuautla, Morelos, Mexico, 62744
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution
  • Poland
      • Gdansk, Poland, 80-546
        • Local Institution
      • Katowice, Poland, 40-057
        • Local Institution
      • Katowice, Poland, 40954
        • Local Institution
      • Krakow, Poland, 30-015
        • Local Institution
      • Lodz, Poland, 90-242
        • Local Institution
      • Opole, Poland, 45-367
        • Local Institution
      • Poznan, Poland, 61-655
        • Local Institution
      • Pulawy, Poland, 24-100
        • Local Institution
      • Warszawa, Poland, 03-580
        • Local Institution
  • Puerto Rico
      • Cidra, Puerto Rico, 00739
        • Local Institution
      • Manati, Puerto Rico, 00674
        • Local Institution
      • Ponce, Puerto Rico, 00716
        • Local Institution
      • San Juan, Puerto Rico, 00909
        • Local Institution
      • San Juan, Puerto Rico, 00926
        • Local Institution
      • San Juan, Puerto Rico, 00935
        • Local Institution
      • Villa Fontana, Puerto Rico, 00983
        • Local Institution
  • Romania
      • Bucharest, Romania, 050538
        • Local Institution
      • Bucuresti, Romania, 020359
        • Local Institution
      • Bucuresti, Romania, 020475
        • Local Institution
      • Bucuresti, Romania, 11794
        • Local Institution
      • Cluj Napoca Cluj, Romania, 400006
        • Local Institution
      • Craiova, Romania, 200349
        • Local Institution
      • Galati, Romania, 800098
        • Local Institution
    • Prahova
      • Ploiesti, Prahova, Romania, 100018
        • Local Institution
      • Ploiesti, Prahova, Romania, 100163
        • Local Institution
    • Timis
      • Timisoara, Timis, Romania, 300736
        • Local Institution
  • South Africa
      • Johannesburg, South Africa, 1829
        • Local Institution
      • Johannesburg, South Africa, 2129
        • Local Institution
    • Gauteng
      • Soweto, Gauteng, South Africa, 2013
        • Local Institution
    • Johannesburg
      • Gauteng, Johannesburg, South Africa, 1818
        • Local Institution
    • Kwa-Zulu Natal
      • Durban, Kwa-Zulu Natal, South Africa, 4001
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Local Institution
      • Goodwood, Western Cape, South Africa, 7460
        • Local Institution
      • Paarl, Western Cape, South Africa, 7646
        • Local Institution
      • Rondebosch, Western Cape, South Africa, 7700
        • Local Institution
      • Somerset West, Western Cape, South Africa, 7130
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
      • Homewood, Alabama, United States, 35244
        • Central Alabama Research
      • Muscle Shoals, Alabama, United States, 35662
        • Terence T. Hart, MD
      • Ozark, Alabama, United States, 36360
        • International Institute Of Clinical Research
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Clinical Research Advantage
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Tucson, Arizona, United States, 85704
        • Genova Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Medical Investigations, Inc.
      • Little Rock, Arkansas, United States, 72211
        • Aureus Research, Inc.
    • California
      • Fountain Valley, California, United States, 92708
        • Southland Clinical Research Center, Inc.
      • Lomita, California, United States, 90717
        • Torrance Clinical Research
      • Los Angeles, California, United States, 90057
        • National Research Inst
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research
      • Northridge, California, United States, 91325
        • Diabetes Medical Center Of California
      • Northridge, California, United States, 91325
        • Mehrdad Kevin Ariani Md, Inc.
      • Norwalk, California, United States, 90650
        • Lucita M. Cruz,Md.,Inc.
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC.
      • Sacramento, California, United States, 95823
        • Center for Clinical Trials of Sacramento, Inc.
      • San Jose, California, United States, 95116
        • Trinitas Research, Inc
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80906
        • Clinical Research Advantage
      • Denver, Colorado, United States, 80246
        • Lynn Institute of Denver
      • Denver, Colorado, United States, 80211
        • InFocus Clinical Research
    • Florida
      • Chiefland, Florida, United States, 32626
        • Southeast Clinical Research, LLC
      • Coral Gables, Florida, United States, 33134
        • Clinical Therapeutics Corporation
      • Jacksonville, Florida, United States, 32216
        • Southeast Clinical Research, LLC
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Miami, Florida, United States, 33136
        • Advanced Pharma Cr, Llc
      • Miami, Florida, United States, 33126
        • Clinical Research Of Miami, Inc.
      • Miami Beach, Florida, United States, 33140
        • Newphase Clinical Trials, Inc.
      • Orlando, Florida, United States, 32804
        • Omega Research Consultants, LLC
      • Palm Harbor, Florida, United States, 34684
        • Palm Harbor Medical Associates
      • Pembroke Pines, Florida, United States, 33026
        • Andres Patron, DO PA
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60607-4559
        • Cedar Crosse Research Center
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Clinical Research Advantage
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas, LLC
    • Michigan
      • Battle Creek, Michigan, United States, 49015
        • Associated Internal Medicine Specialists
      • Detroit, Michigan, United States, 48235
        • Harris And Associates, P.C.
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Patterson Medical Clinic
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Bellevue Family Practice
      • Elkhorn, Nebraska, United States, 68022
        • Clinical Research Advantage
      • Fremont, Nebraska, United States, 68025
        • Clinical Research Advantage
      • Omaha, Nebraska, United States, 68130
        • Clinical Research Advantage
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • South Jersey Medical Associates, P.A.
      • Elizabeth, New Jersey, United States, 07205
        • Central Jersey Health And Medical Research
    • New York
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials, LLC
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endocrinology Consultants
      • Winston-salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Akron, Ohio, United States, 44313
        • Daystar Clinical Resarch, Inc.
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Grp, Ltd.
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Dayton, Ohio, United States, 45419
        • PriMed Clinical Research
      • Zanesville, Ohio, United States, 43701
        • Physicians Research, Inc.
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
      • Portland, Oregon, United States, 97220
        • Oregon Clinical Research
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group
      • Shippensburg, Pennsylvania, United States, 17257
        • Wellmon Family Practice
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • TLM Medical Services
      • Fountain Inn, South Carolina, United States, 29644
        • Palmetto Clinical Trial Services LLC
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Family Research Center, Inc.
      • Corpus Christi, Texas, United States, 78404
        • Padre Coast Clinical Research
      • Dallas, Texas, United States, 75230-2548
        • Dallas Diabetes & Endocrine Center
      • Houston, Texas, United States, 77035
        • Excel Clinical Research, LLC
      • North Richland Hills, Texas, United States, 76180
        • North Hills Medical Research, Inc.
      • Pasadena, Texas, United States, 77504
        • Med-Olam Clinical Research
      • San Antoinio, Texas, United States, 78229
        • Sam Clinical Research Center
      • San Antonio, Texas, United States, 78229
        • Covenant Clinical Research, Pa
      • Waco, Texas, United States, 76710
        • Hillcrest Family Health Center
    • Utah
      • Bountiful, Utah, United States, 84010
        • Val R. Hansen, M.D.
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Med Cntr
    • Virginia
      • Suffolk, Virginia, United States, 23435
        • Hampton Roads Center for Clinical Research, Inc.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
  • Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
  • Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
  • Hepatic disease
  • Cardiovascular disease within 3 months

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: Triple

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.
Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo
Drug: Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Other Names:
  • Onglyza
Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Names:
  • Glucophage XR
Drug: Placebo matching with Dapagliflozin
Tablets, Oral, 0mg, Once daily, 24 weeks
Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo
Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Names:
  • Glucophage XR
Drug: Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Other Names:
  • BMS-512148
Drug: Placebo matching with Saxagliptin
Tablets, Oral, 0mg, Once daily, 24 weeks
Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
Drug: Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Other Names:
  • Onglyza
Drug: Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Other Names:
  • Glucophage XR
Drug: Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Other Names:
  • BMS-512148

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
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
Time Frame: Baseline (Week 0) and at Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
Baseline (Week 0) and at 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
Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])
Time Frame: Baseline (Week 0) and at Week 24
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.
Baseline (Week 0) and at Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline (Week 0) and at Week 24
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
Baseline (Week 0) and at Week 24
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Time Frame: At Week 24
Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
At Week 24
Adjusted Mean Change From Baseline in Body Weight at Week 24
Time Frame: Baseline (Week 0) and at Week 24
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
Baseline (Week 0) and at 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

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.
July 1, 2012

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.
January 1, 2014

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.
January 1, 2014

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).
May 23, 2012

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.
May 24, 2012

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.
May 25, 2012

Study Record Updates

Last Update Posted (Actual)

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 15, 2017

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.
March 29, 2017

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, 2017

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.
  • CV181-169
  • 2012-000679-18 (EudraCT Number)

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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