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 Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 329 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,996 participants
Where: 329 sitesin 16 countries
Study dates: Jul 2010to Feb 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
Serum total bilirubin level >1.5*ULN
Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
Estimated creatinine clearance of <60 mL/min
Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
Creatine kinase >3*ULN

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Positive for hepatitis B surface antigen
Positive for antihepatitis C virus antibody
Abnormal free T4 value
History of diabetes insipidus
Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
History of diabetic ketoacidosis or hyperosmolar nonketotic coma
History of malignant and accelerated hypertension
Known or suspected secondary hypertension
Any of the following within 6 months of enrollment visit:
Myocardial infarction
Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
Unstable angina
Unstable congestive heart disease or New York Heart Association Class III or IV
Transient ischemic attack or significant cerebrovascular disease
Unstable or previously undiagnosed arrhythmia

Trial locations and contacts

329 sites in 16 countries.

Country

City, postcode or hospital

329 sites in 16 countries

United States164 sites

Orange County Research Institute
Anaheim, California, 92801
Cmp Research
Anaheim, California, 92805
Southeastern Research Associates, Inc.
Anderson, South Carolina, 29621
Arlington Family Research Center, Inc.
Arlington, Texas, 76012
Millennium Clinical Trials Llc
Arlington, Virginia, 22203
Perimeter Institute For Clinical Research
Atlanta, Georgia, 30338
Aurora Family Medicine, P.C.
Aurora, Colorado, 80012
American Health Network Of Indiana Llc
Avon, Indiana, 46123
Bainbridge Medical Associates
Bainbridge, Georgia, 39819
Acadia Clinical Research, Llc
Bangor, Maine, 04401
Medical Development Centers, Llc
Baton Rouge, Louisiana, 70808
The Center For Clinical Trials
Biloxi, Mississippi, 39531
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
River Birch Research Alliance, Llc
Blue Ridge, Georgia, 30513
Zasa Clinical Research
Boynton Beach, Florida, 33472
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
Neurocare, Inc.
Brookline, Massachusetts, 02446
Meridien Research
Brooksville, Florida, 34601
Southeastern Pa Medical Institute
Broomall, Pennsylvania, 19008
Investigators Research Group, Llc
Brownsburg, Indiana, 46112
Burke Internal Medicine And Research
Burke, Virginia, 22015
Community Health Care, Inc.
Canal Fulton, Ohio, 44614
Med Center
Carmichael, California, 95608
Barat Research Group, Inc.
Charlotte, North Carolina, 28262
Chattanooga Research & Medicine, Pllc
Chattanooga, Tennessee, 37404
Cedar Crosse Research Center
Chicago, Illinois, 60607
James R. Herron, Md, Ltd
Chicago, Illinois, 60610
Catalina Research Institute, Llc
Chino, California, 91710
Family Care Associates Of Nw Fl
Chipley, Florida, 32428
Community Research
Cincinnati, Ohio, 45227
Innovative Research Of West Florida, Inc
Clearwater, Florida, 33756
Clinical Research Of South Florida
Coral Gables, Florida, 33134
Krk Medical Research
Dallas, Texas, 75230
Research Institute Of Dallas
Dallas, Texas, 75231
Internal Medicine Clinical Research
Dallas, Texas, 75235
Renaissance Clinical Research And Hypertension Pllc
Dallas, Texas, 75235
Avail Clinical Research, Llc
DeLand, Florida, 32720
Horizons Clinical Research Center, Llc
Denver, Colorado, 80220
In Vivo Clinical Research
Doral, Florida, 33166
In-Quest Medical Research, Llc
Duluth, Georgia, 30096
Sergio F. Rovner, M.D.
El Paso, Texas, 79925
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
Genesis Clinical Research, Llc
Fall River, Massachusetts, 02720
Lillestol Research
Fargo, North Dakota, 58103
Abington Memorial Hos/Feasterville Family Health Care Center
Feasterville-Trevose, Pennsylvania, 19053
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708
American Health Network Of In Llc
Franklin, Indiana, 46131
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904
Pharmquest
Greensboro, North Carolina, 27408
Southeastern Research Associates, Inc.
Greenville, South Carolina, 29605
Clin Research Advantage, Inc. James Meli, Do Family Pracice
Henderson, Nevada, 89014
Palm Springs Research Institute
Hialeah, Florida, 33012
The Community Research Of South Florida
Hialeah, Florida, 33016
Mercury Clinical Research
Houston, Texas, 77036
Southwest Clinical Trials
Houston, Texas, 77074
Excel Clinical Research, Llc
Houston, Texas, 77081
Lone Star Clinical Research
Houston, Texas, 77088
Del Rosario Medical Clinic, Inc.
Huntington Park, California, 90255
Time Clinical Research Inc.
Huntington Park, California, 90255
Phillips Medical Services, Pllc
Jackson, Mississippi, 39209
Jefferson City Medical Group
Jefferson City, Missouri, 65109
The Clinical Trial Center, Llc
Jenkintown, Pennsylvania, 19046
Kcumb Dybedal Clinical Research Center
Kansas City, Montana, 64106
Complete Family Care Of Knoxville, Pllc
Knoxville, Tennessee, 37923
Office Of Ted Thorp, Md
Las Vegas, Nevada, 89102
Independent Clinical Researchers@ Wolfson Medical Center
Las Vegas, Nevada, 89103
Clinical Research Advantage, Inc.
Las Vegas, Nevada, 89128
Palm Medical Research Center
Las Vegas, Nevada, 89148
Aureus Research, Inc.
Little Rock, Arkansas, 72211
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Marina Raikhel, M.D., F.A.A.F.P
Lomita, California, 90717
Clinica Medica San Miguel
Los Angeles, California, 90015
American Institute Of Research
Los Angeles, California, 90017
Randall G. Shue, D.O.
Los Angeles, California, 90023
National Research Inst
Los Angeles, California, 90057
Quest Diagnostics West Hills
Los Angeles, California, 90057
Exodus Healthcare Network
Magna, Utah, 84044
Manassas Clinical Research Center
Manassas, Virginia, 20110
Premier Internal Medicine
Memphis, Tennessee, 38119
Crescent City Clinical Research Center
Metairie, Louisiana, 70006
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Flcri Global Research, Llc
Miami, Florida, 33125
International Research Associates, Llc
Miami, Florida, 33125
Clinical Research Of Miami, Inc.
Miami, Florida, 33126
Apf Research, Llc
Miami, Florida, 33135
Community Research Foundation, Inc.
Miami, Florida, 33155
Medical Research Marseilles
Miami, Florida, 33155
Baptist Diabetes Associates, Pa
Miami, Florida, 33156
Newphase Clinical Trials, Inc.
Miami Beach, Florida, 33140
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166
Laporte County Institute For Clinical Research, Inc.
Michigan City, Indiana, 46360
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130
Horizon Research Group, Inc.
Mobile, Alabama, 36608
Burke Primary Care
Morganton, North Carolina, 28655
American Health Network Of In Llc
Muncie, Indiana, 47304
Joslin Diabetes Center Affiliate Of Snhmc
Nashua, New Hampshire, 03063
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, 02740
Hill Country Medical Associates
New Braunfels, Texas, 78130
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Medex Healthcare Research, Inc.
New York, New York, 10022
Digiovanna Institute For Medical Education & Research
North Massapequa, New York, 11758
North Hills Medical Research, Inc.
North Richland Hills, Texas, 76180
Diabetes Medical Center Of California
Northridge, California, 91325
Valley Clinical Trials
Northridge, California, 91325
Lucita M. Cruz,Md.,Inc.
Norwalk, California, 90650
Providence Park Clinical Research
Novi, Michigan, 48374
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
O'Fallon, Illinois, 62269
Integris Family Care Central
Oklahoma City, Oklahoma, 73112
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Sds Clinical Trials
Orange, California, 92868
Compass Research, Llc
Orlando, Florida, 32806
Florida Institute For Clinical Research, Llc
Orlando, Florida, 32822
Iicr, Inc. (International Institute Of Clinical Research)
Ozark, Alabama, 36360
Med-Olam Clinical Research
Pasadena, Texas, 77504
Middle Georgia Clinical Research Center, Llc
Perry, Georgia, 31069
Clinical Research Source, Inc
Perrysburg, Ohio, 43551
Arcuri Clinical Research Llc
Philadelphia, Pennsylvania, 19142
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, 19146
Hope Research Institute
Phoenix, Arizona, 85050
43rd Medical Associates
Phoenix, Arizona, 85051
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216
Lisa E. Medwedeff, Md, Pa
Plano, Texas, 75024
Sound Medical Research
Port Orchard, Washington, 98366
Fanno Creek Clinic
Portland, Oregon, 97219
Research Across America
Reading, Pennsylvania, 19606
Integrated Research Group, Inc.
Riverside, California, 92506
Jackson Clinic
Rolling Fork, Mississippi, 39159
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Quality Control Research, Inc
Sacramento, California, 95842
Wasatch Endocrinology And Diabetes Specialists
Salt Lake City, Utah, 84102
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Sun Research Institute
San Antonio, Texas, 78215
Abbott Clinical Research Group, Inc.
San Antonio, Texas, 78224
Covenant Clinical Research, Pa
San Antonio, Texas, 78229
Crest Clinical Trials, Inc.
Santa Ana, California, 92701
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, 90404
Alternative Primary Care
Silver Spring, Maryland, 20910
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, 29681
South Miami Clinical Research, Llc
South Miami, Florida, 33143
Springfield Diabetes And Endocrine Center
Springfield, Illinois, 62704
St. Louis Center For Clinical Research
St Louis, Missouri, 63128
Meridien Research
St. Petersburg, Florida, 33709
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, 23435
Breco Research, Ltd
Sugarland, Texas, 77479
Pioneer Research Solutions, Inc.
Sugarland, Texas, 77479
Palmetto Clinical Research
Summerville, South Carolina, 29485
Meridien Research
Tampa, Florida, 33606
Central Phoenix Medical Clinic, Llc
Tempe, Arizona, 85282
Clinical Research Advantage/Desert Clinical Research
Tempe, Arizona, 85282
Premier Research
Trenton, New Jersey, 08611
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Eclipse Clinical Research
Tucson, Arizona, 85745
Orange County Research Center
Tustin, California, 92780
University Clinical Investigators, Inc.
Tustin, California, 92780
Pish Medical Associates
Uniontown, Pennsylvania, 15401
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Greater Providence Clinical Research, Llc
Warwick, Rhode Island, 02888
Chase Medical Research, Llc
Waterbury, Connecticut, 06708
Atlantic Clinical Trials, Llc
Watertown, Massachusetts, 02472
Infosphere Clinical Research, Inc.
West Hills, California, 91307
Southgate Medical Group
West Seneca, New York, 14224
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, 28401
Integris Family Care Yukon
Yukon, Oklahoma, 73099

Other trials in United States

Poland26 sites

Local Institution
Bialystok, 15-404
Local Institution
Bydgoszcz, 85-822
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Chrzanów, 32-500
Local Institution
Gdansk, 80-847
Local Institution
Gdynia, 80-384
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Golub-Dobrzyń, 87-400
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Kamieniec Ząbkowicki, 57-230
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Katowice, 40-748
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Krakow, 30-015
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Krakow, 31-159
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Krakow, 31-949
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Lodz, 90-242
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Lodz, 91-078
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Lodz, 92-003
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Ostróda, 14-100
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Poznan, 61-251
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Szczecin, 70-506
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Warsaw, 01-231
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Warsaw, 01-868
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Warsaw, 02-097
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Warsaw, 02-507
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Warsaw, 02-679
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Warsaw, 03-580
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Wroc#Aw, 50-088
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WrocB Aw, 50-349
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Zamość, 22-400

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India20 sites

Local Institution
Bangalore, Karnataka, 560 043
Local Institution
Bangalore, Karnataka, 560043
Local Institution
Bangalore, 560092
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Belagavi, Karnatka, 590010
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Coimbatore, Tamil Nadu, 641018
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Delhi, New Delhi, 110007
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Hyderabad, Andhra Pradesh, 500 034
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Hyderabad, 500063
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Indore, Madhya Pradesh, 452010
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Jaipur, Rajasthan, 202023
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Jaipur, Rajasthan, 302 001
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Jaipur, Rajasthan, 302004
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Madurai, Tamil Nadu, 625020
Local Institution
Manipal, 576104
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Nagpur, Maharashtra, 440010
Local Institution
Nagpur, Maharashtra, 440012
Local Institution
Nagpur, Maharashtra, 440033
Local Institution
Nagpur, 440012
Local Institution
New Delhi, National Capital Territory of Delhi, 110070
Local Institution
Vijayawada, Andhra Pradesh, 520008

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Mexico18 sites

Local Institution
Chihuahua City, Chihuahua, 31217
Local Institution
Cuautla, Morelos, 62744
Local Institution
Culiacán, Sinaloa, 80020
Local Institution
Del. Benito Juarez, Mexico City, 03100
Local Institution
Durango, Durango, 34000
Local Institution
Guadalajara, Jalisco, 44100
Local Institution
Guadalajara, Jalisco, 44600
Local Institution
Guadalajara, Jalisco, 44670
Local Institution
Guadalajara, 44680
Local Institution
Mérida, Yucatán, 97070
Local Institution
Mexico City, Mexico City, 06700
Local Institution
Mexico City, Mexico City, 07760
Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Puebla City, Puebla, 72000
Local Institution
Querétaro City, Querétaro, 76000
Local Institution
Tlalpan, Mexico City, 14000
Local Institution
Torreón, Coahuila, 27000
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Veracruz, Veracruz, 91910

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Germany15 sites

Local Institution
Aschaffenburg, Bavaria, 63739
Local Institution
Bad Kreuznach, 55545
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Berlin, 10787
Local Institution
Duisburg, North Rhine-Westphalia, 47051
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Karlsruhe, 76199
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Köthen, 06366
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Kronshagen, 24119
Local Institution
Langenfeld, 40764
Local Institution
Lüneburg, 21339
Local Institution
Magdeburg, 39112
Local Institution
Mainz, 55116
Local Institution
Mannheim, 68161
Local Institution
Pirna, 01796
Local Institution
Saarbrücken, 66121
Local Institution
Vellmar, Hesse, 34246

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Romania15 sites

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Bucharest, 010496
Local Institution
Bucharest, 011478
Local Institution
Bucharest, 020359
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Bucharest, 020475
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Oradea, Bihor County, 410169
Local Institution
Oradea, Jud. Bihor, 410469
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Ploieşti, Prahova, 100163
Local Institution
Ploieşti, Prahova, 100342
Local Institution
Satu Mare, Satu Mare County, 440055
Local Institution
Sibiu, Sibiu County, 550245
Local Institution
Sibiu, Sibiu County, 550371
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Târgu Mureş, Mureș County, 540098
Local Institution
Târgu Mureş, Mureș County, 540142
Local Institution
Timișoara, Jud. Timis, 300125
Local Institution
Timișoara, Timiș County, 300456

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Russia14 sites

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Dzerzhinskiy, 140091
Local Institution
Krasnoyarsk, 660022
Local Institution
Moscow, 115093
Local Institution
Moscow, 119992
Local Institution
Moscow, 125367
Local Institution
Novosibirsk, 630076
Local Institution
Saint Petersburg, 191119
Local Institution
Saint Petersburg, 195112
Local Institution
Saint Petersburg, 197022
Local Institution
Saratov, 410028
Local Institution
Smolensk, 214018
Local Institution
Yaroslav, 150062
Local Institution
Yaroslavl, 150003
Local Institution
Yaroslavl, 150062

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Peru12 sites

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Arequipa, Arequipa, 54
Local Institution
Arequipa, Arequipa
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Chiclayo, Lambayeque
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Ica, Ica, ICA01
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Lima, Lima Province, 17
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Lima, Lima Province, LIMA 10
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Lima, Lima Province, LIMA 11
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Lima, Lima Province, LIMA 31
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Lima, Lima Province, LIMA 33
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Lince, Lima region, LIMA14
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Hungary11 sites

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Eger, 3300
Local Institution
Gyöngyös, Heves County, 3200
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Hatvan, 3000
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Miskolc, 3530
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Nagykanizsa, 8800
Local Institution
Nyíregyháza, 4400
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Sátoraljaújhely, 3980
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Sopron, 9400
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Szekszárd, H-7100
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Colombia7 sites

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Cali, Valle del Cauca Department, 0000
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Czechia7 sites

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Ostrava, 702 00
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Canada6 sites

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Granby, Quebec, J2G 8Z9
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Kelowona, British Columbia, V1Y 3G8
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Montreal, Quebec, H2R 1V6
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Saskatoon, Saskatchewan, S7K 3H3
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Denmark4 sites

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Puerto Rico4 sites

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Spain4 sites

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Finland2 sites

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About this study

Official title: 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)

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Placebo-matching dapagliflozin
Keywords: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Hypoglycemic Agents, Pharmacologic Actions, Physiological Effects of Drugs
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called BMS-512148
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Placebo-matching dapagliflozinDrug
Oral tablets administered as 0 mg once daily for up to 12 weeks

Study groups in NCT01137474
Study group	Role	What they receive
Dapagliflozin, 10 mg	Experimental	Oral tablets administered as 10 mg once daily for up to 12 weeks Receives: Drug: Dapagliflozin
Placebo-matching dapagliflozin	Placebo comparator	Oral tablets administered once daily in the morning Receives: Drug: Placebo-matching dapagliflozin
Dapagliflozin, 2. 5 mg	Experimental	Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) Receives: Drug: Dapagliflozin
Dapagliflozin, 5 mg	Experimental	Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) Receives: Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Feb 2013

First posted4 Jun 2010 (estimated)
Study startJul 2010
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 2,996 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01137474
Sponsor's protocol ID: MB102-073 ST
Other IDs: 2010-019797-32
Status last verified: Nov 2016
First submitted: 3 Jun 2010
Last updated: 26 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 38770818

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01137474
Acronym / sponsor ID: MB102-073 ST
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,996 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jul 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 4 Jun 2010 (estimated)
Results: Posted 1 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Dapagliflozin, 10 mg	Experimental	Drug: DapagliflozinOral tablets administered as 10 mg once daily for up to 12 weeks
Placebo-matching dapagliflozin	Placebo comparator	Drug: Placebo-matching dapagliflozinOral tablets administered once daily in the morning
Dapagliflozin, 2. 5 mg	Experimental	Drug: DapagliflozinOral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Dapagliflozin, 5 mg	Experimental	Drug: DapagliflozinOral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (21 listed)

Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
Serum total bilirubin level >1.5*ULN
Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
Estimated creatinine clearance of <60 mL/min
Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinAlso: BMS-512148Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks	Drug	Dapagliflozin, 10 mg, Dapagliflozin, 2. 5 mg, Dapagliflozin, 5 mg
Placebo-matching dapagliflozinOral tablets administered as 0 mg once daily for up to 12 weeks	Drug	Placebo-matching dapagliflozin

Primary outcome

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

4 secondary outcomes

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)
Time frame: From Baseline to Week 12
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12
Time frame: From Baseline to Week 12
Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: From Baseline to Week 12
Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12
Time frame: From Baseline to Week 12

Results and safety

Results posted to the registry on 1 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	311	287
Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)	166	154
Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)	165	158
Dapagliflozin 10 mg	302	281

Primary outcome: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12

Time frame: From Baseline to Week 12. Mean (Standard Error). Unit: mm Hg

Measure	Dapagliflozin 10 mg n = 280	Placebo n = 279
Value	-10.40 (0.8822)	-7.34 (0.8812)

Dapagliflozin 10 mg vs Placebo: Mean Difference (Final Values): -3.05 (95% CI -4.87 to -1.24), p = 0.0010, Longitudinal repeated measures analysis

Population analysed: This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.

Primary outcome: Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12

Time frame: From Baseline to Week 12. Mean (Standard Error). Unit: Percent

Measure	Placebo n = 279	Dapagliflozin 10 mg n = 278
Value	-0.10 (0.0631)	-0.56 (0.0633)

Placebo vs Dapagliflozin 10 mg: Mean Difference (Final Values): -0.46 (95% CI -0.59 to -0.33), p <0.0001, Longitudinal repeated measures analysis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 311 (1.3%)	0 of 311 (0%)	Not reported
Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)	3 of 166 (1.8%)	0 of 166 (0%)	Not reported
Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)	2 of 165 (1.2%)	0 of 165 (0%)	Not reported
Dapagliflozin 10 mg	2 of 302 (0.7%)	0 of 302 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale 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.
Redacted\_ProtocolLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

329 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 329 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 329 sites in United States, Poland, India, Mexico, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 (time frame: From Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01137474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.