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
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
2 other identifiers
interventional
2,245
16 countries
298
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Oct 2010
Typical duration for phase_3 type-2-diabetes
298 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
May 23, 2014
CompletedDecember 29, 2016
December 1, 2015
2.3 years
September 3, 2010
February 7, 2014
November 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
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
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 Outcomes (9)
Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)
Baseline, Week 12
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants
Baseline to Week 12
Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)
Baseline, Week 12
Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants
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
Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event
- +4 more secondary outcomes
Study Arms (2)
Dapagliflozin 10 mg
EXPERIMENTALDapagliflozin 10 mg tablets
Placebo matching Dapagliflozin
PLACEBO COMPARATORPlacebo tablets matching dapagliflozin tablets
Interventions
Tablets, Oral, 10 mg, once daily, Up to 12 weeks
Tablets, Oral, 0 mg, once daily, Up to 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (298)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Wilmax Clinical Research, Inc.
Mobile, Alabama, 36608, United States
43rd Medical Associates
Phoenix, Arizona, 85051, United States
Central Phoenix Medical Center
Tempe, Arizona, 85282, United States
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, 85282, United States
Clinical Research Advantage/Desert Clinical Research
Tempe, Arizona, 85282, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
Eclipse Clinical Research
Tucson, Arizona, 85745, United States
Aureus Research, Inc.
Little Rock, Arkansas, 72211, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Cmp Research
Anaheim, California, 92805, United States
Catalina Research Institute, Llc
Chino, California, 91710, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904, United States
Del Rosario Medical Clinic, Inc.
Huntington Park, California, 90255, United States
Time Clinical Research Inc.
Huntington Park, California, 90255, United States
Clinica Medica San Miguel
Los Angeles, California, 90015, United States
American Institute Of Research
Los Angeles, California, 90017, United States
Randall G. Shue, D.O.
Los Angeles, California, 90023, United States
Mcs Clinical Trials
Los Angeles, California, 90057, United States
National Research Inst
Los Angeles, California, 90057, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Lucita M. Cruz,Md.,Inc.
Norwalk, California, 90650, United States
Sds Clinical Trials
Orange, California, 92868, United States
Bayview Research Group, Llc
Paramount, California, 90723, United States
San Diego Managed Care Group
Poway, California, 92064, United States
Integrated Research Group, Inc.
Riverside, California, 92506, United States
Quality Control Research, Inc
Sacramento, California, 95842, United States
Wetlin Research Associates, Inc.
San Diego, California, 92120, United States
Crest Clinical Trials, Inc.
Santa Ana, California, 92701, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, 90404, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Orange County Research Center
Tustin, California, 92780, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Chase Medical Research, Llc
Waterbury, Connecticut, 06708, United States
Christiana Care Health Services, Inc
Newark, Delaware, 19713, United States
Zasa Clinical Research
Boynton Beach, Florida, 33472, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Innovative Research Of West Florida, Inc
Clearwater, Florida, 33756, United States
Clinical Research Of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, Llc
DeLand, Florida, 32720, United States
International Research Associates, Llc
Hialeah, Florida, 33012, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
The Community Research Of South Florida
Hialeah, Florida, 33016, United States
Central Florida Internists
Kissimmee, Florida, 34741, United States
Flcri Global Research, Llc
Miami, Florida, 33125, United States
Clinical Research Of Miami, Inc.
Miami, Florida, 33126, United States
Pharmax Research Clinic, Inc.
Miami, Florida, 33126, United States
Apf Research, Llc
Miami, Florida, 33135, United States
Community Research Foundation, Inc.
Miami, Florida, 33155, United States
Baptist Diabetes Associates, Pa
Miami, Florida, 33156, United States
Newphase Clinical Trials, Inc.
Miami Beach, Florida, 33140, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Florida Institute For Clinical Research, Llc
Orlando, Florida, 32822, United States
Michele A. Morrison Internal Medicine, Inc.
Pembroke Pines, Florida, 33026, United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952, United States
Meridien Research
Tampa, Florida, 33606, United States
Perimeter Institute For Clinical Research
Atlanta, Georgia, 30338, United States
Bainbridge Medical Associates
Bainbridge, Georgia, 39819, United States
River Birch Research Alliance, Llc
Blue Ridge, Georgia, 30513, United States
In-Quest Medical Research, Llc
Duluth, Georgia, 30096, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
O'Fallon, Illinois, 62269, United States
Springfield Diabetes And Endocrine Center
Springfield, Illinois, 62704, United States
American Health Network Of Indiana Llc
Avon, Indiana, 46123, United States
Investigators Research Group, Llc
Brownsburg, Indiana, 46112, United States
American Health Network Of In Llc
Franklin, Indiana, 46131, United States
Laporte County Institute For Clinical Research, Inc.
Michigan City, Indiana, 46360, United States
American Health Network Of In Llc
Muncie, Indiana, 47304, United States
Medical Development Centers, Llc
Baton Rouge, Louisiana, 70808, United States
Omega Clinical Research, Llc
Metairie, Louisiana, 70006, United States
Acadia Clinical Research, Llc
Bangor, Maine, 04401, United States
Alternative Primary Care
Silver Spring, Maryland, 20910, United States
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, 02740, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
Atlantic Clinical Trials, Llc
Watertown, Massachusetts, 02472, United States
Providence Park Clinical Research
Novi, Michigan, 48374, United States
The Center For Clinical Trials
Biloxi, Mississippi, 39531, United States
Phillips Medical Services, Pllc
Jackson, Mississippi, 39209, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
Kcumb Dybedal Clinical Research Center
Kansas City, Missouri, 64106, United States
Clin Research Advantage, Inc. James Meli, Do Family Pracice
Henderson, Nevada, 89014, United States
Office Of Ted Thorp, Md
Las Vegas, Nevada, 89102, United States
Independent Clinical Researchers@ Wolfson Medical Center
Las Vegas, Nevada, 89103, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128, United States
Palm Medical Research Center
Las Vegas, Nevada, 89148, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Premier Research
Trenton, New Jersey, 08611, United States
Medex Healthcare Research, Inc.
New York, New York, 10022, United States
Digiovanna Institute For Medical Education & Research
North Massapequa, New York, 11758, United States
Southgate Medical Group
West Seneca, New York, 14224, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, 28557, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
Lillestol Research
Fargo, North Dakota, 58103, United States
Community Health Care, Inc.
Canal Fulton, Ohio, 44614, United States
Community Research
Cincinnati, Ohio, 45227, United States
Parsons Avenue Medical Clinical
Columbus, Ohio, 43207, United States
Clinical Research Source, Inc
Perrysburg, Ohio, 43551, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Integris Family Care Yukon
Yukon, Oklahoma, 73099, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Southeastern Pa Medical Institute
Broomall, Pennsylvania, 19008, United States
Abington Memorial Hos/Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053, United States
The Clinical Trial Center, Llc
Jenkintown, Pennsylvania, 19046, United States
Arcuri Clinical Research Llc
Philadelphia, Pennsylvania, 19142, United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146, United States
Research Across America
Reading, Pennsylvania, 19606, United States
Pish Medical Associates
Uniontown, Pennsylvania, 15401, United States
Greater Providence Clinical Research, Llc
Warwick, Rhode Island, 02888, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605, United States
North Myrtle Beach Family Practice
North Myrtle Beach, South Carolina, 29582, United States
Pawleys Pediatrics And Adult Medicine
Pawleys Island, South Carolina, 29585, United States
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, 29681, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Southwind Medical Specialists
Memphis, Tennessee, 38125, United States
Tn Medical Research
Spring Hill, Tennessee, 37174, United States
Arlington Family Research Center, Inc.
Arlington, Texas, 76012, United States
3rd Coast Research Associates
Corpus Christi, Texas, 78414, United States
Krk Medical Research
Dallas, Texas, 75230, United States
Research Institute Of Dallas
Dallas, Texas, 75231, United States
Internal Medicine Clinical Reaseach
Dallas, Texas, 75235, United States
Renaissance Clinical Research And Hypertension Pllc
Dallas, Texas, 75235, United States
Sergio F. Rovner, M.D.
El Paso, Texas, 79925, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77008, United States
Village Family Practice
Houston, Texas, 77024, United States
Dependable Clinical Research, Llc
Houston, Texas, 77074, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Bellaire Medical Care Group
Houston, Texas, 77081, United States
Excel Clinical Research, Llc
Houston, Texas, 77081, United States
Hill Country Medical Associates
New Braunfels, Texas, 78130, United States
North Hills Medical Research, Inc.
North Richland Hills, Texas, 76180, United States
Med-Olam Clinical Research
Pasadena, Texas, 77504, United States
Lisa E. Medwedeff, Md, Pa
Plano, Texas, 75024, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Abbott Clinical Research Group, Inc.
San Antonio, Texas, 78224, United States
Covenant Clinical Research, Pa
San Antonio, Texas, 78229, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Breco Research, Ltd
Sugarland, Texas, 77479, United States
Exodus Healthcare Network
Magna, Utah, 84044, United States
Wasatch Endocrinology And Diabetes Specialists
Salt Lake City, Utah, 84102, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Alexandria Health Care Center
Alexandria, Virginia, 22314, United States
Millennium Clinical Trials Llc
Arlington, Virginia, 22203, United States
Burke Internal Medicine And Research
Burke, Virginia, 22015, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, 23435, United States
Larry D. Stonesifer, Md
Federal Way, Washington, 98003, United States
Sound Medical Research
Port Orchard, Washington, 98366, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53142, United States
Local Institution
Camperdown, New South Wales, 2050, Australia
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Heidelberg, Victoria, 3081, Australia
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Nedlands, Western Australia, 6009, Australia
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Kelowona, British Columbia, V1Y 3G8, Canada
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Victoria, British Columbia, V8V 3N7, Canada
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Monction, New Brunswick, E1G 1A7, Canada
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Brampton, Ontario, L6T 3J1, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Montreal, Quebec, H2R 1V6, Canada
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Saskatoon, Saskatchewan, S7K 3H3, Canada
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Armenia, Quindío Department, 0000, Colombia
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Bucaramanga, Santander Department, 0000, Colombia
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Barranquilla, 0000, Colombia
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Barranquilla, Colombia
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Bogotá, 0000, Colombia
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Beroun, 266 01, Czechia
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Cheb, 350 02, Czechia
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Havířov, 736 01, Czechia
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Krnov, 794 01, Czechia
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Liberec, 460 01, Czechia
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Ostrava, 702 00, Czechia
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Prague, 116 94, Czechia
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Prague, 149 00, Czechia
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Copenhagen, DK 2400, Denmark
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Frederiksberg, 2000, Denmark
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Gentofte Municipality, 2820, Denmark
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Slagelse, 4200, Denmark
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Helsinki, 09200, Finland
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Kerava, 04200, Finland
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Kokkola, 67100, Finland
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Oulu, 90100, Finland
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Aschaffenburg, Bavaria, 63739, Germany
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Augsburg, Bavaria, 86150, Germany
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Duisburg, North Rhine-Westphalia, 47051, Germany
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Bad Kreuznach, 55545, Germany
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Berlin, 10787, Germany
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Dortmund, 44137, Germany
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Dresden, 01307, Germany
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Karlsruhe, 76199, Germany
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Köthen, 06366, Germany
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Kronshagen, 24119, Germany
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Langenfeld, 40764, Germany
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Lüneburg, 21339, Germany
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Magdeburg, 39112, Germany
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Mainz, 55116, Germany
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Mannheim, 68161, Germany
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Saarbrücken, 66121, Germany
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Wüstensachsen, 36115, Germany
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Gyöngyös, Heves County, 3200, Hungary
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Budapest, 1134, Hungary
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Budapest, H-1171, Hungary
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Eger, 3300, Hungary
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Kisvárda, 4600, Hungary
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Miskolc, 3530, Hungary
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Nyíregyháza, 4400, Hungary
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Sátoraljaújhely, 3980, Hungary
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Sopron, 9400, Hungary
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Szeged, 6720, Hungary
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Szekszárd, H-7100, Hungary
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Hyderabad, Andhra Pradesh, 5000 18, India
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Bangalore, Karnataka, 560 043, India
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Bangalore, Karnataka, 560043, India
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Bangalore, Karnataka, 560092, India
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Mangalore, Karnataka, 575001, India
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Belagavi, Karnatka, 590010, India
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Indore, Madhya Pradesh, 452010, India
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Nagpur, Maharashtra, 440010, India
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Nagpur, Maharashtra, 440012, India
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Nagpur, Maharashtra, 440033, India
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Delhi, New Delhi, 110007, India
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Jaipur, Rajasthan, 202023, India
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Chennai, Tamil Nadu, 600013, India
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Coimbatore, Tamil Nadu, 641 018, India
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Madurai, Tamil Nadu, 625020, India
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Chennai Tamilnadu, 6000081, India
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Hyderabad, 500063, India
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Nagpur, 440012, India
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Trivandrum, 695011, India
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Dublin, Dublin, Ireland
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Galway, Ireland
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Chihuahua City, Chihuahua, 31217, Mexico
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Torreón, Coahuila, 27000, Mexico
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Guadalajara, Jalisco, 44100, Mexico
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Guadalajara, Jalisco, 44130, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Distrito Federal, Mexico City, 07020, Mexico
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Mexico City, Mexico City, 03300, Mexico
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Mexico City, Mexico City, 07760, Mexico
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Tlalpan, Mexico City, 14000, Mexico
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Cuautla, Morelos, 62744, Mexico
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Monterrey, Nuevo León, 64000, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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San Luis Potosí City, San Luis Potosí, 78200, Mexico
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Culiacán, Sinaloa, 80020, Mexico
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Mérida, Yucatán, 97070, Mexico
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Del. Benito Juarez, 03100, Mexico
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Gdynia, Gdynia, 81-384, Poland
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Bialystok, 15-404, Poland
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Bialystok, 15-879, Poland
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Chrzanów, 32-500, Poland
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Elblag, 82-300, Poland
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Gdansk, 80-847, Poland
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Kamieniec Ząbkowicki, 57-230, Poland
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Katowice, 40-748, Poland
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Kielce, 25-364, Poland
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Krakow, 30-015, Poland
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Krakow, 31-159, Poland
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Lodz, 90-242, Poland
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Lodz, 92-525, Poland
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Lublin, 20-044, Poland
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Ostróda, 14-100, Poland
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Poznan, 61-251, Poland
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Warsaw, 01-192, Poland
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Warsaw, 01-337, Poland
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Warsaw, 01-868, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 50-088, Poland
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Wroclaw, 50-349, Poland
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Zabrze, 41-800, Poland
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Fajard, 00738, Puerto Rico
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Ponce, 00717, Puerto Rico
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San Juan, 00920, Puerto Rico
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Oradea, Bihor County, 410169, Romania
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Oradea, Jud. Bihor, 410469, Romania
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Timișoara, Jud. Timis, 300125, Romania
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Târgu Mureş, Mureș County, 540098, Romania
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Târgu Mureş, Mureș County, 540142, Romania
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Ploieşti, Prahova, 100163, Romania
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Ploieşti, Prahova, 100342, Romania
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Satu Mare, Satu Mare County, 440055, Romania
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Sibiu, Sibiu County, 550371, Romania
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Timișoara, Timiș County, 300456, Romania
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Bucharest, 010507, Romania
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Bucharest, 010719, Romania
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Bucharest, 020475, Romania
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Bucharest, 020725, Romania
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Cluj-Napoca, 400006, Romania
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Sibiu, 550245, Romania
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Irvine, Ayrshire, KA11 1JU, United Kingdom
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Ely, Cambridgeshire, CB7 5JD, United Kingdom
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Birmingham, West Midlands, B9 5SS, United Kingdom
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Bath, Wiltshire, BA2 3HT, United Kingdom
Related Publications (2)
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDWeber 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.
PMID: 26620248DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Totality of data from dapagliflozin development program as of 1 NOV 2011 showed 10 mg dapagliflozin dose provided optimal efficacy, was safe and well tolerated for the general Type 2 diabetes population, allowing the 5 mg arm to be discontinued.
Results Point of Contact
- Title
- AstraZeneca
- Organization
- ClinicalTrialTransparency
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 6, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
December 29, 2016
Results First Posted
May 23, 2014
Record last verified: 2015-12