A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

December 2, 2016 updated by: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2996

Phase

  • 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
    • British Columbia
      • Kelowona, British Columbia, Canada, V1Y 3G8
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3N7
        • Local Institution
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Local Institution
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
        • Local Institution
      • Montreal, Quebec, Canada, H2R 1V6
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Local Institution
  • Colombia
      • Barranquilla, Colombia
        • Local Institution
      • Barranquilla, Colombia, 0000
        • Local Institution
      • Bogota, Colombia, 0000
        • Local Institution
    • Antioquia
      • Medellin, Antioquia, Colombia, 0000
        • Local Institution
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Local Institution
    • Quindio
      • Armenia, Quindio, Colombia, 0000
        • Local Institution
    • Valle
      • Cali, Valle, Colombia, 0000
        • Local Institution
  • Czech Republic
      • Beroun, Czech Republic, 266 01
        • Local Institution
      • Cheb, Czech Republic, 350 02
        • Local Institution
      • Havirov, Czech Republic, 736 01
        • Local Institution
      • Liberec, Czech Republic, 460 01
        • Local Institution
      • Ostrava, Czech Republic, 702 00
        • Local Institution
      • Prague 1, Czech Republic, 116 94
        • Local Institution
      • Praha 4, Czech Republic, 149 00
        • Local Institution
  • Denmark
      • Copenhagen, Denmark, 2300
        • Local Institution
      • Copenhagen, Denmark, 2400
        • Local Institution
      • Frederiksberg, Denmark, DK-2000
        • Local Institution
      • Slagelse, Denmark, 4200
        • Local Institution
  • Finland
      • Kokkola, Finland, 67100
        • Local Institution
      • Oulu, Finland, 90100
        • Local Institution
  • Germany
      • Bad Kreuznach, Germany, 55545
        • Local Institution
      • Berlin, Germany, 10787
        • Local Institution
      • Karlsruhe, Germany, 76199
        • Local Institution
      • Kothen, Germany, 06366
        • Local Institution
      • Kronshagen, Germany, 24119
        • Local Institution
      • Langenfeld, Germany, 40764
        • Local Institution
      • Lueneburg, Germany, 21339
        • Local Institution
      • Magdeburg, Germany, 39112
        • Local Institution
      • Mainz, Germany, 55116
        • Local Institution
      • Mannheim, Germany, 68161
        • Local Institution
      • Pirna, Germany, 01796
        • Local Institution
      • Saarbruecken, Germany, 66121
        • Local Institution
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63739
        • Local Institution
    • Hessen
      • Vellmar, Hessen, Germany, 34246
        • Local Institution
    • Nordrhein-Westfalen
      • Duisburg, Nordrhein-Westfalen, Germany, 47051
        • Local Institution
  • Hungary
      • Eger, Hungary, 3300
        • Local Institution
      • Hatvan, Hungary, 3000
        • Local Institution
      • Miskolc, Hungary, 3530
        • Local Institution
      • Nagykanizsa, Hungary, 8800
        • Local Institution
      • Nyiregyhaza, Hungary, 4400
        • Local Institution
      • Satoraljaujhely, Hungary, 3980
        • Local Institution
      • Sopron, Hungary, 9400
        • Local Institution
      • Szeged, Hungary, 6720
        • Local Institution
      • Szekszard, Hungary, H-7100
        • Local Institution
      • Szentes, Hungary, 6600
        • Local Institution
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Local Institution
  • India
      • Bangalore, India, 560092
        • Local Institution
      • Hyderabad, India, 500063
        • Local Institution
      • Manipal, India, 576104
        • Local Institution
      • Nagpur, India, 440012
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 034
        • Local Institution
      • Vijayawada, Andhra Pradesh, India, 520008
        • Local Institution
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Local Institution
    • Karnataka
      • Bangalore, Karnataka, India, 560 043
        • Local Institution
      • Bangalore, Karnataka, India, 560043
        • Local Institution
    • Karnatka
      • Belgaum, Karnatka, India, 590010
        • Local Institution
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Local Institution
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Local Institution
      • Nagpur, Maharashtra, India, 440012
        • Local Institution
      • Nagpur, Maharashtra, India, 440033
        • Local Institution
    • New Delhi
      • Delhi, New Delhi, India, 110007
        • Local Institution
    • Rajasthan
      • Jaipur, Rajasthan, India, 202023
        • Local Institution
      • Jaipur, Rajasthan, India, 302 001
        • Local Institution
      • Jaipur, Rajasthan, India, 302004
        • Local Institution
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641018
        • Local Institution
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Local Institution
  • Mexico
      • Chihuahua, Mexico, 31217
        • Local Institution
      • Durango, Mexico, 34000
        • Local Institution
      • Guadalajara, Mexico, 44680
        • Local Institution
      • Puebla, Mexico, 72000
        • Local Institution
      • Queretaro, Mexico, 76000
        • Local Institution
      • Veracruz, Mexico, 91910
        • Local Institution
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Local Institution
    • Distrito Federal
      • Del. Benito Juarez, Distrito Federal, Mexico, 03100
        • Local Institution
      • Mexico City, Distrito Federal, Mexico, 07760
        • Local Institution
      • Mexico, Df, Distrito Federal, Mexico, 06700
        • Local Institution
      • Tlalpan, Distrito Federal, Mexico, 14000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44100
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44600
        • Local Institution
    • Morelos
      • Cuautla, Morelos, Mexico, 62744
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Arequipa, Peru, 54
        • Local Institution
      • Cusco, Peru
        • Local Institution
      • Ica, Peru, ICA01
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, LIMA 31
        • Local Institution
      • Lima, Peru, 17
        • Local Institution
      • Lima, Peru, LIMA 10
        • Local Institution
      • Lima, Peru, LIMA 33
        • Local Institution
      • Piura, Peru
        • Local Institution
    • Lambayeque
      • Chiclayo, Lambayeque, Peru
        • Local Institution
    • Lima
      • Lince, Lima, Peru, LIMA14
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-404
        • Local Institution
      • Bydgoszcz, Poland, 85-822
        • Local Institution
      • Chrzanow, Poland, 32-500
        • Local Institution
      • Gdansk, Poland, 80-847
        • Local Institution
      • Gdynia, Poland, 80-384
        • Local Institution
      • Golub-Dobrzyn, Poland, 87-400
        • Local Institution
      • Kamieniec Zabkowicki, Poland, 57-230
        • Local Institution
      • Katowice, Poland, 40-748
        • Local Institution
      • Krakow, Poland, 30-015
        • Local Institution
      • Krakow, Poland, 31-159
        • Local Institution
      • Krakow, Poland, 31-949
        • Local Institution
      • Lodz, Poland, 90-242
        • Local Institution
      • Lodz, Poland, 91-078
        • Local Institution
      • Lodz, Poland, 92-003
        • Local Institution
      • Ostroda, Poland, 14-100
        • Local Institution
      • Poznan, Poland, 61-251
        • Local Institution
      • Szczecin, Poland, 70-506
        • Local Institution
      • Warsaw, Poland, 01-231
        • Local Institution
      • Warsaw, Poland, 02-097
        • Local Institution
      • Warszawa, Poland, 01-868
        • Local Institution
      • Warszawa, Poland, 02-507
        • Local Institution
      • Warszawa, Poland, 03-580
        • Local Institution
      • Warszawa, Poland, 02-679
        • Local Institution
      • Wroc#Aw, Poland, 50-088
        • Local Institution
      • WrocB Aw, Poland, 50-349
        • Local Institution
      • Zamosc, Poland, 22-400
        • Local Institution
  • Puerto Rico
      • Cidra, Puerto Rico, 00739
        • Local Institution
      • Ponce, Puerto Rico, 00716
        • Local Institution
      • Ponce, Puerto Rico, 00717
        • Local Institution
      • San Juan, Puerto Rico, 00918
        • Local Institution
  • Romania
      • Bucuresti, Romania, 020359
        • Local Institution
      • Bucuresti, Romania, 020475
        • Local Institution
      • Bucuresti, Romania, 010496
        • Local Institution
      • Bucuresti, Romania, 011478
        • Local Institution
      • Satu Mare, Romania, 440055
        • Local Institution
      • Sibiu, Romania, 550245
        • Local Institution
      • Sibiu, Romania, 550371
        • Local Institution
    • Bihor
      • Oradea, Bihor, Romania, 410169
        • Local Institution
    • Jud. Bihor
      • Oradea, Jud. Bihor, Romania, 410469
        • Local Institution
    • Jud. Timis
      • Timisoara, Jud. Timis, Romania, 300125
        • Local Institution
    • Mures
      • Targu Mures, Mures, Romania, 540098
        • Local Institution
      • Targu Mures, Mures, Romania, 540142
        • Local Institution
    • Prahova
      • Ploiesti, Prahova, Romania, 100163
        • Local Institution
      • Ploiesti, Prahova, Romania, 100342
        • Local Institution
    • Timis
      • Timisoara, Timis, Romania, 300456
        • Local Institution
  • Russian Federation
      • Dzerzhinskiy, Russian Federation, 140091
        • Local Institution
      • Krasnoyarsk, Russian Federation, 660022
        • Local Institution
      • Moscow, Russian Federation, 119992
        • Local Institution
      • Moscow, Russian Federation, 125367
        • Local Institution
      • Moscow, Russian Federation, 115093
        • Local Institution
      • Novosibirsk, Russian Federation, 630076
        • Local Institution
      • Saint Petersburg, Russian Federation, 197022
        • Local Institution
      • Saratov, Russian Federation, 410028
        • Local Institution
      • Smolensk, Russian Federation, 214018
        • Local Institution
      • St. Petersburg, Russian Federation, 191119
        • Local Institution
      • St.Petersburg, Russian Federation, 195112
        • Local Institution
      • Yaroslav, Russian Federation, 150062
        • Local Institution
      • Yaroslavl, Russian Federation, 150062
        • Local Institution
      • Yaroslavl, Russian Federation, 150003
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • La Roca Del Valles, Spain, 08430
        • Local Institution
      • Peralada, Spain, 17491
        • Local Institution
    • A Coruna
      • Santiago De Compostela, A Coruna, Spain, 15706
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Mobile, Alabama, United States, 36608
        • Horizon Research Group, Inc.
      • Ozark, Alabama, United States, 36360
        • Iicr, Inc. (International Institute Of Clinical Research)
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85051
        • 43rd Medical Associates
      • Tempe, Arizona, United States, 85282
        • Central Phoenix Medical Clinic, LLC
      • Tempe, Arizona, United States, 85282
        • Clinical Research Advantage/Desert Clinical Research
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
      • Little Rock, Arkansas, United States, 72211
        • Aureus Research, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Orange County Research Institute
      • Anaheim, California, United States, 92805
        • Cmp Research
      • Carmichael, California, United States, 95608
        • Med Center
      • Chino, California, United States, 91710
        • Catalina Research Institute, LLC
      • Fountain Valley, California, United States, 92708
        • Southland Clinical Research Center, Inc.
      • Greenbrae, California, United States, 94904
        • Marin Endocrine Care & Research, Inc.
      • Huntington Park, California, United States, 90255
        • Del Rosario Medical Clinic, Inc.
      • Huntington Park, California, United States, 90255
        • Time Clinical Research Inc.
      • Lomita, California, United States, 90717
        • Marina Raikhel, M.D., F.A.A.F.P
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Los Angeles, California, United States, 90057
        • National Research Inst
      • Los Angeles, California, United States, 90015
        • Clinica Medica San Miguel
      • Los Angeles, California, United States, 90023
        • Randall G. Shue, D.O.
      • Los Angeles, California, United States, 90057
        • Quest Diagnostics West Hills
      • Northridge, California, United States, 91325
        • Diabetes Medical Center Of California
      • Northridge, California, United States, 91325
        • Valley Clinical Trials
      • Norwalk, California, United States, 90650
        • Lucita M. Cruz,Md.,Inc.
      • Orange, California, United States, 92868
        • SDS Clinical Trials
      • Riverside, California, United States, 92506
        • Integrated Research Group, Inc.
      • Sacramento, California, United States, 95842
        • Quality Control Research, Inc
      • Santa Ana, California, United States, 92701
        • Crest Clinical Trials, Inc.
      • Santa Monica, California, United States, 90404
        • Orrin M. Troum, MD and Medical Associates
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • West Hills, California, United States, 91307
        • Infosphere Clinical Research, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Family Medicine, P.C.
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Zasa Clinical Research
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Chipley, Florida, United States, 32428
        • Family Care Associates Of Nw Fl
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida, Inc
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Deland, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Doral, Florida, United States, 33166
        • In Vivo Clinical Research
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research Institute
      • Hialeah, Florida, United States, 33016
        • The Community Research of South Florida
      • Miami, Florida, United States, 33015
        • San Marcus Research Clinic, Inc.
      • Miami, Florida, United States, 33155
        • Community Research Foundation, Inc.
      • Miami, Florida, United States, 33135
        • APF Research, LLC
      • Miami, Florida, United States, 33156
        • Baptist Diabetes Associates, PA
      • Miami, Florida, United States, 33126
        • Clinical Research Of Miami, Inc.
      • Miami, Florida, United States, 33125
        • Flcri Global Research, Llc
      • Miami, Florida, United States, 33125
        • International Research Associates, LLC
      • Miami, Florida, United States, 33155
        • Medical Research Marseilles
      • Miami Beach, Florida, United States, 33140
        • Newphase Clinical Trials, Inc.
      • Miami Springs, Florida, United States, 33166
        • Ocean Blue Medical Research Center, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Orlando, Florida, United States, 32822
        • Florida Institute For Clinical Research, LLC
      • South Miami, Florida, United States, 33143
        • South Miami Clinical Research, LLC
      • St Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33606
        • Meridien Research
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute For Clinical Research
      • Bainbridge, Georgia, United States, 39819
        • Bainbridge Medical Associates
      • Blue Ridge, Georgia, United States, 30513
        • River Birch Research Alliance, LLC
      • Duluth, Georgia, United States, 30096
        • In-Quest Medical Research, LLC
      • Perry, Georgia, United States, 31069
        • Middle Georgia Clinical Research Center, Llc
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Center
      • Chicago, Illinois, United States, 60610
        • James R. Herron, Md, Ltd
      • O?Fallon, Illinois, United States, 62269
        • So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
      • Springfield, Illinois, United States, 62704
        • Springfield Diabetes and Endocrine Center
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana LLC
      • Brownsburg, Indiana, United States, 46112
        • Investigators Research Group, Llc
      • Franklin, Indiana, United States, 46131
        • American Health Network of IN LLC
      • Michigan City, Indiana, United States, 46360
        • Laporte County Institute For Clinical Research, Inc.
      • Muncie, Indiana, United States, 47304
        • American Health Network of IN LLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Medical Development Centers, LLC
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Acadia Clinical Research, LLC
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Alternative Primary Care
    • Massachusetts
      • Brookline, Massachusetts, United States, 02446
        • Neurocare, Inc.
      • Fall River, Massachusetts, United States, 02720
        • Genesis Clinical Research, LLC
      • New Bedford, Massachusetts, United States, 02740
        • Hci-Metromedic Walk-In Medical Office
      • Watertown, Massachusetts, United States, 02472
        • Atlantic Clinical Trials, Llc
    • Michigan
      • Novi, Michigan, United States, 48374
        • Providence Park Clinical Research
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • The Center for Clinical Trials
      • Jackson, Mississippi, United States, 39209
        • Phillips Medical Services, PLLC
      • Rolling Fork, Mississippi, United States, 39159
        • Jackson Clinic
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Montana
      • Kansas City, Montana, United States, 64106
        • Kcumb Dybedal Clinical Research Center
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Clin Research Advantage, Inc. James Meli, Do Family Pracice
      • Las Vegas, Nevada, United States, 89128
        • Clinical Research Advantage, Inc.
      • Las Vegas, Nevada, United States, 89148
        • Palm Medical Research Center
      • Las Vegas, Nevada, United States, 89102
        • Office Of Ted Thorp, Md
      • Las Vegas, Nevada, United States, 89103
        • Independent Clinical Researchers@ Wolfson Medical Center
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Joslin Diabetes Center Affiliate Of Snhmc
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Central Jersey Medical Research Center
      • Trenton, New Jersey, United States, 08611
        • Premier Research
    • New York
      • New York, New York, United States, 10022
        • Medex Healthcare Research, Inc.
      • North Massapequa, New York, United States, 11758
        • DiGiovanna Institute for Medical Education & Research
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Barat Research Group, Inc.
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Morganton, North Carolina, United States, 28655
        • Burke Primary Care
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research
    • Ohio
      • Canal Fulton, Ohio, United States, 44614
        • Community Health Care, Inc.
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Middleburg Heights, Ohio, United States, 44130
        • Cleveland Sleep Research Center
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Family Care Central
      • Yukon, Oklahoma, United States, 73099
        • Integris Family Care Yukon
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
      • Portland, Oregon, United States, 97219
        • Fanno Creek Clinic
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Southeastern PA Medical Institute
      • Feasterville Trevose, Pennsylvania, United States, 19053
        • Abington Memorial Hos/Feasterville Family Health Care Center
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19142
        • Arcuri Clinical Research Llc
      • Philadelphia, Pennsylvania, United States, 19146
        • Philadelphia Health Associates - Adult Medicine
      • Pittsburgh, Pennsylvania, United States, 15216
        • Banksville Medical Pc
      • Reading, Pennsylvania, United States, 19606
        • Research Across America
      • Uniontown, Pennsylvania, United States, 15401
        • Pish Medical Associates
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • Greater Providence Clinical Research, LLC
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Southeastern Research Associates, Inc.
      • Greenville, South Carolina, United States, 29605
        • Southeastern Research Associates, Inc.
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Reseach, Llc
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Research & Medicine, PLLC
      • Knoxville, Tennessee, United States, 37923
        • Complete Family Care Of Knoxville, Pllc
      • Memphis, Tennessee, United States, 38119
        • Premier Internal Medicine
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Family Research Center, Inc.
      • Dallas, Texas, United States, 75231
        • Research Institute of Dallas
      • Dallas, Texas, United States, 75230
        • KRK Medical Research
      • Dallas, Texas, United States, 75235
        • Internal Medicine Clinical Research
      • Dallas, Texas, United States, 75235
        • Renaissance Clinical Research And Hypertension Pllc
      • El Paso, Texas, United States, 79925
        • Sergio F. Rovner, M.D.
      • Houston, Texas, United States, 77074
        • Southwest Clinical Trials
      • Houston, Texas, United States, 77036
        • Mercury Clinical Research
      • Houston, Texas, United States, 77081
        • Excel Clinical Research, LLC
      • Houston, Texas, United States, 77088
        • Lone Star Clinical Research
      • New Braunfels, Texas, United States, 78130
        • Hill Country Medical Associates
      • North Richland Hills, Texas, United States, 76180
        • North Hills Medical Research, Inc.
      • Pasadena, Texas, United States, 77504
        • Med-Olam Clinical Research
      • Plano, Texas, United States, 75024
        • Lisa E. Medwedeff, Md, Pa
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • San Antonio, Texas, United States, 78229
        • Covenant Clinical Research, Pa
      • San Antonio, Texas, United States, 78224
        • Abbott Clinical Research Group, Inc.
      • Sugarland, Texas, United States, 77479
        • Breco Research, Ltd
      • Sugarland, Texas, United States, 77479
        • Pioneer Research Solutions, Inc.
    • Utah
      • Magna, Utah, United States, 84044
        • Exodus Healthcare Network
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
      • Salt Lake City, Utah, United States, 84102
        • Wasatch Endocrinology And Diabetes Specialists
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Millennium Clinical Trials LLC
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine and Research
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Suffolk, Virginia, United States, 23435
        • Hampton Roads Center for Clinical Research, Inc.
      • Virginia Beach, Virginia, United States, 23454
        • Tidewater Integrated Medical Research
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Sound Medical Research

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

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion criteria

  • Participants willing and able to give signed and written informed consent
  • Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
  • Mean 24-hour BP>=130/80 mmHg determined by ABPM
  • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
  • C-peptide level ≥0.8 ng/mL
  • Body mass index ≤ 45.0 kg/m^2

Key exclusion criteria

  • Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
  • Serum total bilirubin level >1.5*ULN
  • Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
  • Estimated creatinine clearance of <60 mL/min
  • Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
  • Creatine kinase >3*ULN
  • Positive for hepatitis B surface antigen
  • Positive for antihepatitis C virus antibody
  • Abnormal free T4 value
  • History of diabetes insipidus
  • Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • History of malignant and accelerated hypertension
  • Known or suspected secondary hypertension

  • Any of the following within 6 months of enrollment visit:

    • Myocardial infarction
    • Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
    • Unstable angina
    • Unstable congestive heart disease or New York Heart Association Class III or IV
    • Transient ischemic attack or significant cerebrovascular disease
    • Unstable or previously undiagnosed arrhythmia

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dapagliflozin, 10 mg
Oral tablets administered as 10 mg once daily for up to 12 weeks
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Names:
  • BMS-512148
PLACEBO_COMPARATOR: Placebo-matching dapagliflozin
Oral tablets administered once daily in the morning
Drug: Placebo-matching dapagliflozin
Oral tablets administered as 0 mg once daily for up to 12 weeks
EXPERIMENTAL: Dapagliflozin, 2. 5 mg
Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Names:
  • BMS-512148
EXPERIMENTAL: Dapagliflozin, 5 mg
Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Names:
  • BMS-512148

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
Time Frame: From Baseline to Week 12
Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
From Baseline to Week 12
Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12
Time Frame: From Baseline to Week 12
HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
From Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)
Time Frame: From Baseline to Week 12
Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
From Baseline to Week 12
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12
Time Frame: From Baseline to Week 12
All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
From Baseline to Week 12
Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])
Time Frame: From Baseline to Week 12
Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
From Baseline to Week 12
Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12
Time Frame: From Baseline to Week 12
Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
From Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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.

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

July 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (ESTIMATE)

June 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2017

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-073 ST
  • 2010-019797-32 (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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