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
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)
2 other identifiers
interventional
2,996
16 countries
329
Brief Summary
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.
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 Jul 2010
Typical duration for phase_3 type-2-diabetes
329 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
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
July 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 1, 2014
CompletedJanuary 26, 2017
November 1, 2016
2.6 years
June 3, 2010
February 7, 2014
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at 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
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 Outcomes (4)
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)
From Baseline to Week 12
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12
From Baseline to Week 12
Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])
From Baseline to Week 12
Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12
From Baseline to Week 12
Study Arms (4)
Dapagliflozin, 10 mg
EXPERIMENTALOral tablets administered as 10 mg once daily for up to 12 weeks
Placebo-matching dapagliflozin
PLACEBO COMPARATOROral tablets administered once daily in the morning
Dapagliflozin, 2. 5 mg
EXPERIMENTALOral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Dapagliflozin, 5 mg
EXPERIMENTALOral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Interventions
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Oral tablets administered as 0 mg once daily for up to 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Aspartate aminotransferase or alanine aminotransferase level \>3\*upper limit of normal (ULN)
- Serum total bilirubin level \>1.5\*ULN
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (329)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Iicr, Inc. (International Institute Of Clinical Research)
Ozark, Alabama, 36360, United States
Hope Research Institute
Phoenix, Arizona, 85050, United States
43rd Medical Associates
Phoenix, Arizona, 85051, United States
Central Phoenix Medical Clinic, Llc
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
Orange County Research Institute
Anaheim, California, 92801, United States
Cmp Research
Anaheim, California, 92805, United States
Med Center
Carmichael, California, 95608, 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
Marina Raikhel, M.D., F.A.A.F.P
Lomita, California, 90717, 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
National Research Inst
Los Angeles, California, 90057, United States
Quest Diagnostics West Hills
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
Integrated Research Group, Inc.
Riverside, California, 92506, United States
Quality Control Research, Inc
Sacramento, California, 95842, United States
Crest Clinical Trials, Inc.
Santa Ana, California, 92701, United States
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, 90404, United States
Orange County Research Center
Tustin, California, 92780, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Infosphere Clinical Research, Inc.
West Hills, California, 91307, United States
Aurora Family Medicine, P.C.
Aurora, Colorado, 80012, United States
Horizons Clinical Research Center, Llc
Denver, Colorado, 80220, United States
Chase Medical Research, Llc
Waterbury, Connecticut, 06708, United States
Zasa Clinical Research
Boynton Beach, Florida, 33472, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Meridien Research
Brooksville, Florida, 34601, United States
Family Care Associates Of Nw Fl
Chipley, Florida, 32428, 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
In Vivo Clinical Research
Doral, Florida, 33166, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
The Community Research Of South Florida
Hialeah, Florida, 33016, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33015, United States
Flcri Global Research, Llc
Miami, Florida, 33125, United States
International Research Associates, Llc
Miami, Florida, 33125, United States
Clinical Research Of Miami, Inc.
Miami, Florida, 33126, United States
Apf Research, Llc
Miami, Florida, 33135, United States
Community Research Foundation, Inc.
Miami, Florida, 33155, United States
Medical Research Marseilles
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
Compass Research, Llc
Orlando, Florida, 32806, United States
Florida Institute For Clinical Research, Llc
Orlando, Florida, 32822, United States
South Miami Clinical Research, Llc
South Miami, Florida, 33143, United States
Meridien Research
St. Petersburg, Florida, 33709, 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 Clinical Research Center, Llc
Perry, Georgia, 31069, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
James R. Herron, Md, Ltd
Chicago, Illinois, 60610, 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
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Acadia Clinical Research, Llc
Bangor, Maine, 04401, United States
Alternative Primary Care
Silver Spring, Maryland, 20910, United States
Neurocare, Inc.
Brookline, Massachusetts, 02446, United States
Genesis Clinical Research, Llc
Fall River, Massachusetts, 02720, United States
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, 02740, 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
Jackson Clinic
Rolling Fork, Mississippi, 39159, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
St. Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Kcumb Dybedal Clinical Research Center
Kansas City, Montana, 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
Joslin Diabetes Center Affiliate Of Snhmc
Nashua, New Hampshire, 03063, United States
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202, 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
Barat Research Group, Inc.
Charlotte, North Carolina, 28262, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, 28401, 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
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130, United States
Clinical Research Source, Inc
Perrysburg, Ohio, 43551, United States
Integris Family Care Central
Oklahoma City, Oklahoma, 73112, 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
Fanno Creek Clinic
Portland, Oregon, 97219, United States
Southeastern Pa Medical Institute
Broomall, Pennsylvania, 19008, United States
Abington Memorial Hos/Feasterville Family Health Care Center
Feasterville-Trevose, 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
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216, 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
Southeastern Research Associates, Inc.
Anderson, South Carolina, 29621, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605, United States
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, 29681, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Chattanooga Research & Medicine, Pllc
Chattanooga, Tennessee, 37404, United States
Complete Family Care Of Knoxville, Pllc
Knoxville, Tennessee, 37923, United States
Premier Internal Medicine
Memphis, Tennessee, 38119, United States
Arlington Family Research Center, Inc.
Arlington, Texas, 76012, United States
Krk Medical Research
Dallas, Texas, 75230, United States
Research Institute Of Dallas
Dallas, Texas, 75231, United States
Internal Medicine Clinical Research
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
Mercury Clinical Research
Houston, Texas, 77036, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Excel Clinical Research, Llc
Houston, Texas, 77081, United States
Lone Star Clinical Research
Houston, Texas, 77088, 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
Breco Research, Ltd
Sugarland, Texas, 77479, United States
Pioneer Research Solutions, Inc.
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
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
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Sound Medical Research
Port Orchard, Washington, 98366, United States
Local Institution
Kelowona, British Columbia, V1Y 3G8, Canada
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Victoria, British Columbia, V8V 3N7, Canada
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Brampton, Ontario, L6T 0G1, 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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Medellín, Antioquia, 0000, Colombia
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Bogota, Cundinamarca, 0000, Colombia
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Armenia, Quindío Department, 0000, Colombia
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Cali, Valle del Cauca 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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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, 2300, Denmark
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Copenhagen, 2400, Denmark
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Frederiksberg, DK-2000, Denmark
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Slagelse, 4200, Denmark
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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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Vellmar, Hesse, 34246, 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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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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Pirna, 01796, Germany
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Saarbrücken, 66121, Germany
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Gyöngyös, Heves County, 3200, Hungary
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Eger, 3300, Hungary
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Hatvan, 3000, Hungary
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Miskolc, 3530, Hungary
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Nagykanizsa, 8800, 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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Szentes, 6600, Hungary
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Hyderabad, Andhra Pradesh, 500 034, India
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Vijayawada, Andhra Pradesh, 520008, India
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Bangalore, Karnataka, 560 043, India
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Bangalore, Karnataka, 560043, 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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New Delhi, National Capital Territory of Delhi, 110070, India
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Delhi, New Delhi, 110007, India
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Jaipur, Rajasthan, 202023, India
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Jaipur, Rajasthan, 302 001, India
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Jaipur, Rajasthan, 302004, India
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Coimbatore, Tamil Nadu, 641018, India
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Madurai, Tamil Nadu, 625020, India
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Bangalore, 560092, India
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Hyderabad, 500063, India
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Manipal, 576104, India
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Nagpur, 440012, India
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Chihuahua City, Chihuahua, 31217, Mexico
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Torreón, Coahuila, 27000, Mexico
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Durango, Durango, 34000, Mexico
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Guadalajara, Jalisco, 44100, Mexico
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Guadalajara, Jalisco, 44600, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Del. Benito Juarez, Mexico City, 03100, Mexico
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Mexico City, Mexico City, 06700, 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, 64460, Mexico
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Puebla City, Puebla, 72000, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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Culiacán, Sinaloa, 80020, Mexico
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Veracruz, Veracruz, 91910, Mexico
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Mérida, Yucatán, 97070, Mexico
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Guadalajara, 44680, Mexico
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Arequipa, Arequipa, 54, Peru
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Arequipa, Arequipa, Peru
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Cusco, Departamento de Cusco, Peru
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Ica, Ica, ICA01, Peru
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Chiclayo, Lambayeque, Peru
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Lima, Lima Province, 17, Peru
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Lima, Lima Province, LIMA 10, Peru
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Lima, Lima Province, LIMA 11, Peru
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Lima, Lima Province, LIMA 31, Peru
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Lima, Lima Province, LIMA 33, Peru
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Lince, Lima region, LIMA14, Peru
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Piura, Piura, Peru
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Bialystok, 15-404, Poland
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Bydgoszcz, 85-822, Poland
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Chrzanów, 32-500, Poland
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Gdansk, 80-847, Poland
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Gdynia, 80-384, Poland
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Golub-Dobrzyń, 87-400, Poland
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Kamieniec Ząbkowicki, 57-230, Poland
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Katowice, 40-748, Poland
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Krakow, 30-015, Poland
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Krakow, 31-159, Poland
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Krakow, 31-949, Poland
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Lodz, 90-242, Poland
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Lodz, 91-078, Poland
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Lodz, 92-003, Poland
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Ostróda, 14-100, Poland
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Poznan, 61-251, Poland
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Szczecin, 70-506, Poland
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Warsaw, 01-231, 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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Warsaw, 02-679, Poland
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Warsaw, 03-580, Poland
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Wroc#Aw, 50-088, Poland
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WrocB Aw, 50-349, Poland
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Zamość, 22-400, Poland
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Cidra, 00739, Puerto Rico
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Ponce, 00716, Puerto Rico
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Ponce, 00717, Puerto Rico
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San Juan, 00918, 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, 550245, Romania
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Sibiu, Sibiu County, 550371, Romania
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Timișoara, Timiș County, 300456, Romania
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Bucharest, 010496, Romania
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Bucharest, 011478, Romania
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Bucharest, 020359, Romania
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Bucharest, 020475, Romania
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Dzerzhinskiy, 140091, Russia
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Krasnoyarsk, 660022, Russia
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Moscow, 115093, Russia
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Moscow, 119992, Russia
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Moscow, 125367, Russia
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Novosibirsk, 630076, Russia
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Saint Petersburg, 191119, Russia
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Saint Petersburg, 195112, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410028, Russia
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Smolensk, 214018, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150062, Russia
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Yaroslav, 150062, Russia
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Santiago de Compostela, A Coruna, 15706, Spain
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Barcelona, 08036, Spain
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La Roca del Vallès, 08430, Spain
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Peralada, 17491, Spain
Related Publications (1)
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: 38770818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study originally had 2 additional arms, dapagliflozin 2.5 and 5 mg, but enrolment stopped after Protocol Amendment 8 (1-11-11) implemented. Because endpoints focused on comparison of dapagliflozin 10 mg with placebo, only these arms were summarized.
Results Point of Contact
- Title
- AstraZeneca
- Organization
- Clinical Trial Transparency
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
June 3, 2010
First Posted
June 4, 2010
Study Start
July 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 26, 2017
Results First Posted
May 1, 2014
Record last verified: 2016-11