A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Last updated: November 20, 2018
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT02551874
CV181-369
2015-001702-33
  • Ages 18-120
  • All Genders

Study Summary

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Eligibility Criteria

Inclusion

For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com Inclusion Criteria:

  • At least 18 years of age at screening

  • HbA1c ≥ 8% and ≤ 12% at screening

  • Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)

  • Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks

  • estimated glomerular filtration rate (eGFR) < 60 ml/ml/1.73m2

  • Body Mass Index ≤ 45.0 kg/m2

Exclusion

Exclusion Criteria:

  • Clinical diagnosis of Type 1 diabetes

  • History of ketoacidosis

  • Renal, hepatic or pancreatic disease

  • Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

  • Cardiovascular or vascular diseases identified within 3 months ofparticipationImpairment of renal function (defined as creatinine clearance [CrCl] < 60mL/min

Study Design

Total Participants: 650
Study Start date:
October 20, 2015
Estimated Completion Date:
November 10, 2017

Study Description

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Connect with a study center

  • Local Institution

    Aeikolskaat, 370 01
    Czech Republic

    Site Not Available

  • Local Institution

    Ceske Budejovice, 370 01
    Czech Republic

    Site Not Available

  • Local Institution

    Cheb, 350 02
    Czech Republic

    Site Not Available

  • Local Institution

    Havirov, 736 01
    Czech Republic

    Site Not Available

  • Local Institution

    Novy Jicin, 741 01
    Czech Republic

    Site Not Available

  • Local Institution

    Prague 10, 102 00
    Czech Republic

    Site Not Available

  • Local Institution

    Praha, 169 02
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 4, 14021
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 5, 150 00
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 5 Stodulky, 155 00
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 5-StodAlky, 155 00
    Czech Republic

    Site Not Available

  • Research Site

    Praha 6,
    Czech Republic

    Site Not Available

  • Research Site

    Karlovy Vary, 360 01
    Czechia

    Site Not Available

  • Research Site

    Olomouc, 772 00
    Czechia

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  • Local Institution

    Copenhagen, 2100
    Denmark

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  • Local Institution

    Gentofte, 2820
    Denmark

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  • Local Institution

    Hellerup, 2900
    Denmark

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  • Research Site

    Hvidovre,
    Denmark

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  • Research Site

    Koebenhavn, 2400
    Denmark

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  • Local Institution

    Silkeborg, 8600
    Denmark

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  • Local Institution

    Berlin, 10409
    Germany

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  • Local Institution

    Essen, 45355
    Germany

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  • Local Institution

    Frankfurt, 60596
    Germany

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    Hamburg, 22607
    Germany

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    Leipzig, 04103
    Germany

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  • Local Institution

    Saarlouis, 66740
    Germany

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  • Local Institution

    Baja, 6500
    Hungary

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  • Research Site

    Budapest, 1097
    Hungary

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  • Local Institution

    Letavertes, 4281
    Hungary

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    Mako, 6900
    Hungary

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    Szekszard, 7100
    Hungary

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  • Local Institution

    Colonia Centro, Chihuahua 31000
    Mexico

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  • Local Institution

    Del. Benito Juarez, Distrito Federal 03100
    Mexico

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  • Local Institution

    Merida, Yucatan 97129
    Mexico

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  • Local Institution

    Col San Pedro De Los Pinos,
    Mexico

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  • Research Site

    Guadalajara, 44670
    Mexico

    Site Not Available

  • Research Site

    Mexico, 03800
    Mexico

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  • Research Site

    Monterrey, 64460
    Mexico

    Site Not Available

  • Local Institution

    Zapopan, 45116
    Mexico

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  • Research Site

    Zapopan, Jalisco, 45200
    Mexico

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  • Local Institution

    Zgierz, Lodzkie 95100
    Poland

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  • Local Institution

    Bialystok, 15-794
    Poland

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  • Local Institution

    Gdansk-stogi, 80-631
    Poland

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  • Local Institution

    Gdnask, 80-546
    Poland

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  • Local Institution

    Katowice, 40-954
    Poland

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  • Local Institution

    Krakow, 30002
    Poland

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  • Research Site

    Lodz, 92-003
    Poland

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  • Research Site

    Nowy Duninow, 09-505
    Poland

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  • Local Institution

    Poznan, 61-251
    Poland

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  • Research Site

    Sochaczew, 96-500
    Poland

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  • Local Institution

    Szczecin, 70-376
    Poland

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  • Local Institution

    Warsaw, 02-106
    Poland

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  • Local Institution

    Warszawa, 04-736
    Poland

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  • Local Institution

    Wroclaw, 51-685
    Poland

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  • Local Institution

    Bacau, 605400
    Romania

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  • Research Site

    Craiova, 200349
    Romania

    Site Not Available

  • Local Institution

    Galati, 800098
    Romania

    Site Not Available

  • Research Site

    Ploiesti, 100018
    Romania

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  • Research Site

    Timisoara, 300125
    Romania

    Site Not Available

  • Research Site

    Timișoara, 300456
    Romania

    Site Not Available

  • Local Institution

    Chelyabinsk, 454047
    Russian Federation

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  • Local Institution

    Kursk, 305004
    Russian Federation

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  • Local Institution

    Moscow, 119034
    Russian Federation

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  • Research Site

    Novosibirsk,
    Russian Federation

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  • Research Site

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Smolensk,
    Russian Federation

    Site Not Available

  • Local Institution

    St Petersburg, 197341
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersburg,
    Russian Federation

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  • Local Institution

    Tyumen, 625023
    Russian Federation

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  • Local Institution

    Yaroslavl, 150062
    Russian Federation

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  • Local Institution

    Bloemfontein, Free State 9301
    South Africa

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  • Local Institution

    Halfway House, Gauteng 1685
    South Africa

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    Johannesburg, Gauteng 2198
    South Africa

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    Pretoria West, Gauteng 0183
    South Africa

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  • Local Institution

    Umkomaas, Kwa-Zulu Natal 4170
    South Africa

    Site Not Available

  • Local Institution

    Krugersdorp, 1738
    South Africa

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  • Research Site

    Lenasia, 1827
    South Africa

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  • Local Institution

    Pretoria, 0158
    South Africa

    Site Not Available

  • Local Institution

    Alzira, Valencia 46600
    Spain

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    A Coru?a, 15006
    Spain

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    A Coruna, 15006
    Spain

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    Alicante,
    Spain

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    Almeria, 04001
    Spain

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    Almería,
    Spain

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    Barcelona,
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  • Research Site

    La Coruña, 15006
    Spain

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    Palma de Mallorca, 07014
    Spain

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    Sevilla, 41009
    Spain

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    Valencia, 46026
    Spain

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    Harnosand, 87182
    Sweden

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    Lund, 222 22
    Sweden

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    Motala, 591 85
    Sweden

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    Stenungsund, 444 31
    Sweden

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    Uddevalla, 451 80
    Sweden

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  • Local Institution

    Vallingby, 162 68
    Sweden

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    Vastra Frolunda, 421 44
    Sweden

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  • Research Site

    Vällingby,
    Sweden

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  • Clinical Trial Connection

    Camp Verde, Arizona 86322
    United States

    Site Not Available

  • Central Phoenix Medical Clinic, Llc

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Lynn Institute Of The Ozarks

    Little Rock, Arkansas 72205
    United States

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    Anaheim, California 92801
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  • Valley Research

    Fresno, California 93720
    United States

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  • National Research Institute

    Huntington Park, California 90255
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  • Research Site

    Los Angeles, California 90057
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  • Providence Clinical Research

    North Hollywood, California 91606
    United States

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  • Diabetes Associates Medical Group

    Orange, California 92868
    United States

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  • Local Institution

    San Mateo, California 94401
    United States

    Site Not Available

  • Local Institution

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Infosphere Clinical Research, Inc.

    West Hills, California 91307
    United States

    Site Not Available

  • Lynn Institute Of The Rockies

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Local Institution

    Boca Raton, Florida 33065
    United States

    Site Not Available

  • Meridien Research

    Bradenton, Florida 34208
    United States

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  • Local Institution

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Trials Management Of Boca Raton

    Coral Springs, Florida 33065
    United States

    Site Not Available

  • The University Of Florida College Of Medicine

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Newphase Clinical Trials, Inc.

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Central Florida Internists

    Orlando, Florida 32811
    United States

    Site Not Available

  • Research Site

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Research Site

    Tampa, Florida
    United States

    Site Not Available

  • Research Site

    Norcross, Georgia 30071
    United States

    Site Not Available

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Christie Clinic

    Champaign, Illinois 61822
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Midwest Crc

    Crystal Lake, Illinois 60012
    United States

    Site Not Available

  • Associates In Endocrinology, Inc- Elgin

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40502
    United States

    Site Not Available

  • Omega Clinical Research, Llc

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Local Institution

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Local Institution

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Research Site

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Southern Nh Diab And Endo

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Metrolina Internal Medicine

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Clinical Trials Of America, Inc.

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Local Institution

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Research Site

    Beavercreek, Ohio 45432
    United States

    Site Not Available

  • Research Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Research Site

    Barto, Pennsylvania 19504
    United States

    Site Not Available

  • Heritage Valley Medical Group

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Detweiler Family Medicine And Associates, Pc

    Lansdale, Pennsylvania 19446
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Research Site

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Carolina Health Specialists

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Research Site

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Clinical Research Solutions

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Research Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Pmg Research Of Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

  • Amarillo Medical Specialists

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Rockwood Medical Clinic

    Fort Worth, Texas 76164
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Research Site

    Mesquite, Texas 74194
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Research Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manasses, Virginia 20110
    United States

    Site Not Available

  • Local Institution

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Hampton Roads Center For Clinical Research, Inc.

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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