A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

November 10, 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 (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

The purpose of this study is to learn if BMS-512148 (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 (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

Study Overview

Status

Completed

Conditions

Type 2 Diabetes

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2245

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

Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Local Institution
- Victoria
  - Heidelberg, Victoria, Australia, 3081
    - Local Institution
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Local Institution
Canada
- British Columbia
  - Kelowona, British Columbia, Canada, V1Y 3G8
    - Local Institution
  - Victoria, British Columbia, Canada, V8V 3N7
    - Local Institution
- New Brunswick
  - Monction, New Brunswick, Canada, E1G 1A7
    - Local Institution
- Ontario
  - Brampton, Ontario, Canada, L6T 3J1
    - 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
- Quindio
  - Armenia, Quindio, Colombia, 0000
    - Local Institution
- Santander
  - Bucaramanga, Santander, 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
  - Krnov, Czech Republic, 794 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, DK 2400
    - Local Institution
  - Frederiksberg, Denmark, 2000
    - Local Institution
  - Gentofte, Denmark, 2820
    - Local Institution
  - Slagelse, Denmark, 4200
    - Local Institution
Finland
- - Helsinki, Finland, 09200
    - Local Institution
  - Kerava, Finland, 04200
    - Local Institution
  - Kokkola, Finland, 67100
    - Local Institution
  - Oulu, Finland, 90100
    - Local Institution
Germany
- - Bad Kreuznach, Germany, 55545
    - Local Institution
  - Berlin, Germany, 10787
    - Local Institution
  - Dortmund, Germany, 44137
    - Local Institution
  - Dresden, Germany, 01307
    - 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
  - Saarbruecken, Germany, 66121
    - Local Institution
  - Wuestensachsen, Germany, 36115
    - Local Institution
- Bavaria
  - Aschaffenburg, Bavaria, Germany, 63739
    - Local Institution
  - Augsburg, Bavaria, Germany, 86150
    - Local Institution
- Nordrhein-Westfalen
  - Duisburg, Nordrhein-Westfalen, Germany, 47051
    - Local Institution
Hungary
- - Budapest, Hungary, 1134
    - Local Institution
  - Budapest, Hungary, H-1171
    - Local Institution
  - Eger, Hungary, 3300
    - Local Institution
  - Kisvarda, Hungary, 4600
    - Local Institution
  - Miskolc, Hungary, 3530
    - 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
- Heves
  - Gyongyos, Heves, Hungary, 3200
    - Local Institution
India
- - Chennai Tamilnadu, India, 6000081
    - Local Institution
  - Hyderabad, India, 500063
    - Local Institution
  - Nagpur, India, 440012
    - Local Institution
  - Trivandrum, India, 695011
    - Local Institution
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 5000 18
    - Local Institution
- Karnataka
  - Bangalore, Karnataka, India, 560 043
    - Local Institution
  - Bangalore, Karnataka, India, 560043
    - Local Institution
  - Bangalore, Karnataka, India, 560092
    - Local Institution
  - Mangalore, Karnataka, India, 575001
    - 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
- Tamil Nadu
  - Chennai, Tamil Nadu, India, 600013
    - Local Institution
  - Coimbatore, Tamil Nadu, India, 641 018
    - Local Institution
- Tamilnadu
  - Madurai, Tamilnadu, India, 625020
    - Local Institution
Ireland
- - Galway, Ireland
    - Local Institution
- Dublin
  - Dublin 15, Dublin, Ireland
    - Local Institution
Mexico
- - Chihuahua, Mexico, 31217
    - Local Institution
  - Del. Benito Juarez, Mexico, 03100
    - Local Institution
  - Delegacion Tlalpan, Mexico, 14000
    - Local Institution
  - Distrito Federal, Mexico, 07020
    - Local Institution
  - San Luis Potosi, Mexico, 78200
    - Local Institution
- Coahuila
  - Torreon, Coahuila, Mexico, 27000
    - Local Institution
- Distrito Federal
  - Mexico City, Distrito Federal, Mexico, 07760
    - Local Institution
  - Mexico City, Distrito Federal, Mexico, 03300
    - Local Institution
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Local Institution
  - Guadalajara, Jalisco, Mexico, 44100
    - Local Institution
  - Guadalajara, Jalisco, Mexico, 44130
    - Local Institution
- Morelos
  - Cuautla, Morelos, Mexico, 62744
    - Local Institution
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64460
    - Local Institution
  - Monterrey, Nuevo Leon, Mexico, 64000
    - Local Institution
- Sinaloa
  - Culiacan, Sinaloa, Mexico, 80020
    - Local Institution
- Yucatan
  - Merida, Yucatan, Mexico, 97070
    - Local Institution
Poland
- - Bialystok, Poland, 15-404
    - Local Institution
  - Bialystok, Poland, 15-879
    - Local Institution
  - Chrzanow, Poland, 32-500
    - Local Institution
  - Elblag, Poland, 82-300
    - Local Institution
  - Gdansk, Poland, 80-847
    - Local Institution
  - Gdynia, Poland, 81-384
    - Local Institution
  - Kamieniec Zabkowicki, Poland, 57-230
    - Local Institution
  - Katowice, Poland, 40-748
    - Local Institution
  - Kielce, Poland, 25-364
    - Local Institution
  - Krakow, Poland, 30-015
    - Local Institution
  - Krakow, Poland, 31-159
    - Local Institution
  - Lodz, Poland, 90-242
    - Local Institution
  - Lodz, Poland, 92-525
    - Local Institution
  - Lublin, Poland, 20-044
    - Local Institution
  - Ostroda, Poland, 14-100
    - Local Institution
  - Poznan, Poland, 61-251
    - Local Institution
  - Warsaw, Poland, 02-097
    - Local Institution
  - Warsaw, Poland, 02-507
    - Local Institution
  - Warszawa, Poland, 01-868
    - Local Institution
  - Warszawa, Poland, 01-192
    - Local Institution
  - Warszawa, Poland, 01-337
    - Local Institution
  - Wroclaw, Poland, 50-349
    - Local Institution
  - Wroclaw, Poland, 50-088
    - Local Institution
  - Zabrze, Poland, 41-800
    - Local Institution
Puerto Rico
- - Fajard, Puerto Rico, 00738
    - Local Institution
  - Ponce, Puerto Rico, 00717
    - Local Institution
  - San Juan, Puerto Rico, 00920
    - Local Institution
Romania
- - Bucuresti, Romania, 010507
    - Local Institution
  - Bucuresti, Romania, 020475
    - Local Institution
  - Bucuresti, Romania, 010719
    - Local Institution
  - Bucuresti, Romania, 020725
    - Local Institution
  - Cluj-Napoca, Romania, 400006
    - 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
United Kingdom
- Ayrshire
  - Irvine, Ayrshire, United Kingdom, KA11 1JU
    - Local Institution
- Cambridgeshire
  - Ely, Cambridgeshire, United Kingdom, CB7 5JD
    - Local Institution
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B9 5SS
    - Local Institution
- Wiltshire
  - Bath, Wiltshire, United Kingdom, BA2 3HT
    - Local Institution
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama at Birmingham
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center, Inc.
  - Mobile, Alabama, United States, 36608
    - Wilmax Clinical Research, Inc.
- Arizona
  - Phoenix, Arizona, United States, 85051
    - 43rd Medical Associates
  - Tempe, Arizona, United States, 85282
    - Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
  - Tempe, Arizona, United States, 85282
    - Clinical Research Advantage/Desert Clinical Research
  - Tempe, Arizona, United States, 85282
    - Central Phoenix Medical Center
  - 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, 92805
    - Cmp Research
  - 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.
  - Los Angeles, California, United States, 90017
    - American Institute of Research
  - Los Angeles, California, United States, 90057
    - Mcs Clinical Trials
  - 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.
  - 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
  - Paramount, California, United States, 90723
    - Bayview Research Group, LLC
  - Poway, California, United States, 92064
    - San Diego Managed Care Group
  - Riverside, California, United States, 92506
    - Integrated Research Group, Inc.
  - Sacramento, California, United States, 95842
    - Quality Control Research, Inc
  - San Diego, California, United States, 92120
    - Wetlin Research Associates, Inc.
  - Santa Ana, California, United States, 92701
    - Crest Clinical Trials, Inc.
  - Santa Monica, California, United States, 90404
    - Neurological Research Institute
  - Santa Monica, California, United States, 90404
    - Orrin M. Troum, MD and Medical Associates
  - Torrance, California, United States, 90505
    - Torrance Clinical Research
  - Tustin, California, United States, 92780
    - University Clinical Investigators, Inc.
  - Tustin, California, United States, 92780
    - Orange County Research Center
- Connecticut
  - Waterbury, Connecticut, United States, 06708
    - Chase Medical Research, LLC
- Delaware
  - Newark, Delaware, United States, 19713
    - Christiana Care Health Services, Inc
- Florida
  - Boynton Beach, Florida, United States, 33472
    - Zasa Clinical Research
  - Bradenton, Florida, United States, 34205
    - Bradenton Research Center, Inc.
  - 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
  - Hialeah, Florida, United States, 33012
    - Palm Springs Research Institute
  - Hialeah, Florida, United States, 33012
    - International Research Associates, LLC
  - Hialeah, Florida, United States, 33016
    - The Community Research of South Florida
  - Kissimmee, Florida, United States, 34741
    - Central Florida Internists
  - Miami, Florida, United States, 33126
    - Pharmax 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 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, 32822
    - Florida Institute For Clinical Research, LLC
  - Pembroke Pines, Florida, United States, 33026
    - Michele A. Morrison Internal Medicine, Inc.
  - Port Charlotte, Florida, United States, 33952
    - Medsol Clinical Research Center
  - 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 Drug Study Center, Llc
- Illinois
  - Chicago, Illinois, United States, 60607
    - Cedar Crosse Research Center
  - 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
    - Omega Clinical Research, Llc
- Maine
  - Bangor, Maine, United States, 04401
    - Acadia Clinical Research, LLC
- Maryland
  - Silver Spring, Maryland, United States, 20910
    - Alternative Primary Care
- Massachusetts
  - New Bedford, Massachusetts, United States, 02740
    - Hci-Metromedic Walk-In Medical Office
  - Newton, Massachusetts, United States, 02459
    - Neurocare, Inc.
  - 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
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Jefferson City Medical Group
  - Kansas City, Missouri, 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 Jersey
  - Berlin, New Jersey, United States, 08009
    - Comprehensive Clinical Research
  - 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
  - Morehead City, North Carolina, United States, 28557
    - Diabetes & Endocrinology Consultants
  - Morganton, North Carolina, United States, 28655
    - Burke Primary Care
- 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
  - Columbus, Ohio, United States, 43207
    - Parsons Avenue Medical Clinical
  - Perrysburg, Ohio, United States, 43551
    - Clinical Research Source, Inc
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Sooner Clinical Research
  - Yukon, Oklahoma, United States, 73099
    - Integris Family Care Yukon
- Oregon
  - Eugene, Oregon, United States, 97404
    - Willamette Valley Clinical Studies
- Pennsylvania
  - Broomall, Pennsylvania, United States, 19008
    - Southeastern PA Medical Institute
  - Feasterville, 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
  - 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
  - Charleston, South Carolina, United States, 29407
    - Medical Research South
  - Greenville, South Carolina, United States, 29605
    - Southeastern Research Associates, Inc.
  - North Myrtle Beach, South Carolina, United States, 29582
    - North Myrtle Beach Family Practice
  - Pawleys Island, South Carolina, United States, 29585
    - Pawleys Pediatrics And Adult Medicine
  - Simpsonville, South Carolina, United States, 29681
    - Hillcrest Clinical Reseach, Llc
  - Summerville, South Carolina, United States, 29485
    - Palmetto Clinical Research
- Tennessee
  - Memphis, Tennessee, United States, 38125
    - Southwind Medical Specialists
  - Spring Hill, Tennessee, United States, 37174
    - Tn Medical Research
- Texas
  - Arlington, Texas, United States, 76012
    - Arlington Family Research Center, Inc.
  - Corpus Christi, Texas, United States, 78414
    - 3rd Coast Research Associates
  - Dallas, Texas, United States, 75231
    - Research Institute of Dallas
  - Dallas, Texas, United States, 75230
    - KRK Medical Research
  - Dallas, Texas, United States, 75235
    - Renaissance Clinical Research And Hypertension Pllc
  - Dallas, Texas, United States, 75235
    - Internal Medicine Clinical Reaseach
  - El Paso, Texas, United States, 79925
    - Sergio F. Rovner, M.D.
  - Houston, Texas, United States, 77074
    - Southwest Clinical Trials
  - Houston, Texas, United States, 77008
    - Pioneer Research Solutions, Inc.
  - Houston, Texas, United States, 77024
    - Village Family Practice
  - Houston, Texas, United States, 77081
    - Excel Clinical Research, LLC
  - Houston, Texas, United States, 77074
    - Dependable Clinical Research, Llc
  - Houston, Texas, United States, 77081
    - Bellaire Medical Care Group
  - 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
    - Innovative Clinical Trials
  - 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
- 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
  - Alexandria, Virginia, United States, 22314
    - Alexandria Health Care Center
  - 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.
- Washington
  - Federal Way, Washington, United States, 98003
    - Larry D. Stonesifer, Md
  - Port Orchard, Washington, United States, 98366
    - Sound Medical Research
- Wisconsin
  - Kenosha, Wisconsin, United States, 53142
    - Clinical Investigation Specialists, 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

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Written informed consent
Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
C-peptide ≥ 0.8 ng/mL
Body Mass Index ≤ 45.0 kg/m2
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper limit of normal (ULN)
Serum total bilirubin ≥ 1.5*ULN
Creatinine kinase > 3*ULN
Symptoms of severely uncontrolled diabetes
History of malignant or accelerated hypertension
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dapagliflozin 10 mg Dapagliflozin 10 mg tablets	Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, Up to 12 weeks Other Names: BMS-512148 Farxiga™
PLACEBO_COMPARATOR: Placebo matching Dapagliflozin Placebo tablets matching dapagliflozin tablets	Drug: Placebo matching Dapagliflozin Tablets, Oral, 0 mg, once daily, Up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants Time Frame: Baseline to Week 12	Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken 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 obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.	Baseline to Week 12
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants Time Frame: Baseline to Week 12	Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.	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 (LOCF) Time Frame: Baseline, Week 12	Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.	Baseline, Week 12
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants Time Frame: Baseline to Week 12	Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken 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 obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.	Baseline to Week 12
Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF) Time Frame: Baseline, Week 12	Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.	Baseline, Week 12
Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants Time Frame: Baseline, Week 12	Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.	Baseline, Week 12
Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue Time Frame: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event	Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.	Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event
Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days	Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.	Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days
Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days	Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3ULN); ALP (>1.5ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.	Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue Time Frame: Baseline, Week 12	12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.	Baseline, Week 12
Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue Time Frame: Baseline (Day 1), Week 12	Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.	Baseline (Day 1), 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.

General Publications

Weber MA, Mansfield TA, Cain VA, Iqbal N, Parikh S, Ptaszynska A. Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Diabetes Endocrinol. 2016 Mar;4(3):211-220. doi: 10.1016/S2213-8587(15)00417-9. Epub 2015 Nov 27. Erratum In: Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3. Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3.

Helpful Links

BMS clinical trial educational resource

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

October 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (ESTIMATE)

September 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MB102-077 ST
2010-019798-13 (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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Type 2 Diabetes

Clinical Trials on Dapagliflozin

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