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
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01137474
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2996
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin, 10 mg Dapagliflozin Oral tablets administered as 10 mg once daily for up to 12 weeks Placebo-matching dapagliflozin Placebo-matching dapagliflozin Oral tablets administered once daily in the morning Dapagliflozin, 5 mg Dapagliflozin Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) Dapagliflozin, 2. 5 mg Dapagliflozin Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 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 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.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 From Baseline to Week 12 All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) From Baseline to Week 12 Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) From Baseline to Week 12 Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.
Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12 From Baseline to Week 12 Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.
Trial Locations
- Locations (161)
Arcuri Clinical Research Llc
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia Health Associates - Adult Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
National Research Inst
🇺🇸Los Angeles, California, United States
Quest Diagnostics West Hills
🇺🇸Los Angeles, California, United States
Clinica Medica San Miguel
🇺🇸Los Angeles, California, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Flcri Global Research, Llc
🇺🇸Miami, Florida, United States
International Research Associates, Llc
🇺🇸Miami, Florida, United States
Clinical Research Of Miami, Inc.
🇺🇸Miami, Florida, United States
Apf Research, Llc
🇺🇸Miami, Florida, United States
Community Research Foundation, Inc.
🇺🇸Miami, Florida, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Lone Star Clinical Research
🇺🇸Houston, Texas, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
43rd Medical Associates
🇺🇸Phoenix, Arizona, United States
Palm Medical Research Center
🇺🇸Las Vegas, Nevada, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Integris Family Care Central
🇺🇸Oklahoma City, Oklahoma, United States
Independent Clinical Researchers@ Wolfson Medical Center
🇺🇸Las Vegas, Nevada, United States
Clinical Research Advantage, Inc.
🇺🇸Las Vegas, Nevada, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Abbott Clinical Research Group, Inc.
🇺🇸San Antonio, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Covenant Clinical Research, Pa
🇺🇸San Antonio, Texas, United States
Wasatch Endocrinology And Diabetes Specialists
🇺🇸Salt Lake City, Utah, United States
Aurora Family Medicine, P.C.
🇺🇸Aurora, Colorado, United States
Horizons Clinical Research Center, Llc
🇺🇸Denver, Colorado, United States
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
Arlington Family Research Center, Inc.
🇺🇸Arlington, Texas, United States
Excel Clinical Research, Llc
🇺🇸Houston, Texas, United States
Horizon Research Group, Inc.
🇺🇸Mobile, Alabama, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Clinical Research Advantage/Desert Clinical Research
🇺🇸Tempe, Arizona, United States
American Institute Of Research
🇺🇸Los Angeles, California, United States
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
Cmp Research
🇺🇸Anaheim, California, United States
Aureus Research, Inc.
🇺🇸Little Rock, Arkansas, United States
Marin Endocrine Care & Research, Inc.
🇺🇸Greenbrae, California, United States
Del Rosario Medical Clinic, Inc.
🇺🇸Huntington Park, California, United States
The Center For Clinical Trials
🇺🇸Biloxi, Mississippi, United States
Jackson Clinic
🇺🇸Rolling Fork, Mississippi, United States
Clin Research Advantage, Inc. James Meli, Do Family Pracice
🇺🇸Henderson, Nevada, United States
Kcumb Dybedal Clinical Research Center
🇺🇸Kansas City, Montana, United States
Pharmquest
🇺🇸Greensboro, North Carolina, United States
Cleveland Sleep Research Center
🇺🇸Middleburg Heights, Ohio, United States
Integris Family Care Yukon
🇺🇸Yukon, Oklahoma, United States
Banksville Medical Pc
🇺🇸Pittsburgh, Pennsylvania, United States
Southeastern Research Associates, Inc.
🇺🇸Greenville, South Carolina, United States
Complete Family Care Of Knoxville, Pllc
🇺🇸Knoxville, Tennessee, United States
Local Institution
🇪🇸Peralada, Spain
Breco Research, Ltd
🇺🇸Sugarland, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Visions Clinical Research - Tucson
🇺🇸Tucson, Arizona, United States
Med Center
🇺🇸Carmichael, California, United States
Catalina Research Institute, Llc
🇺🇸Chino, California, United States
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
Sds Clinical Trials
🇺🇸Orange, California, United States
Orrin M. Troum, Md And Medical Associates
🇺🇸Santa Monica, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Zasa Clinical Research
🇺🇸Boynton Beach, Florida, United States
Family Care Associates Of Nw Fl
🇺🇸Chipley, Florida, United States
Avail Clinical Research, Llc
🇺🇸Deland, Florida, United States
The Community Research Of South Florida
🇺🇸Hialeah, Florida, United States
Medical Research Marseilles
🇺🇸Miami, Florida, United States
Bainbridge Medical Associates
🇺🇸Bainbridge, Georgia, United States
Perimeter Institute For Clinical Research
🇺🇸Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
James R. Herron, Md, Ltd
🇺🇸Chicago, Illinois, United States
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
🇺🇸O?Fallon, Illinois, United States
American Health Network Of Indiana Llc
🇺🇸Avon, Indiana, United States
Acadia Clinical Research, Llc
🇺🇸Bangor, Maine, United States
Alternative Primary Care
🇺🇸Silver Spring, Maryland, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States
Phillips Medical Services, Pllc
🇺🇸Jackson, Mississippi, United States
St. Louis Center For Clinical Research
🇺🇸St. Louis, Missouri, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Digiovanna Institute For Medical Education & Research
🇺🇸North Massapequa, New York, United States
Community Health Care, Inc.
🇺🇸Canal Fulton, Ohio, United States
Clinical Research Source, Inc
🇺🇸Perrysburg, Ohio, United States
Abington Memorial Hos/Feasterville Family Health Care Center
🇺🇸Feasterville Trevose, Pennsylvania, United States
Pish Medical Associates
🇺🇸Uniontown, Pennsylvania, United States
The Clinical Trial Center, Llc
🇺🇸Jenkintown, Pennsylvania, United States
Greater Providence Clinical Research, Llc
🇺🇸Warwick, Rhode Island, United States
Hillcrest Clinical Reseach, Llc
🇺🇸Simpsonville, South Carolina, United States
Krk Medical Research
🇺🇸Dallas, Texas, United States
Research Institute Of Dallas
🇺🇸Dallas, Texas, United States
Renaissance Clinical Research And Hypertension Pllc
🇺🇸Dallas, Texas, United States
Internal Medicine Clinical Research
🇺🇸Dallas, Texas, United States
Mercury Clinical Research
🇺🇸Houston, Texas, United States
Med-Olam Clinical Research
🇺🇸Pasadena, Texas, United States
Burke Internal Medicine And Research
🇺🇸Burke, Virginia, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Hampton Roads Center For Clinical Research, Inc.
🇺🇸Suffolk, Virginia, United States
Central Phoenix Medical Clinic, Llc
🇺🇸Tempe, Arizona, United States
Iicr, Inc. (International Institute Of Clinical Research)
🇺🇸Ozark, Alabama, United States
Time Clinical Research Inc.
🇺🇸Huntington Park, California, United States
Crest Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
Marina Raikhel, M.D., F.A.A.F.P
🇺🇸Lomita, California, United States
Randall G. Shue, D.O.
🇺🇸Los Angeles, California, United States
Lucita M. Cruz,Md.,Inc.
🇺🇸Norwalk, California, United States
In Vivo Clinical Research
🇺🇸Doral, Florida, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
Infosphere Clinical Research, Inc.
🇺🇸West Hills, California, United States
Integrated Research Group, Inc.
🇺🇸Riverside, California, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
Medical Development Centers, Llc
🇺🇸Baton Rouge, Louisiana, United States
Chase Medical Research, Llc
🇺🇸Waterbury, Connecticut, United States
Innovative Research Of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Clinical Research Of South Florida
🇺🇸Coral Gables, Florida, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Newphase Clinical Trials, Inc.
🇺🇸Miami Beach, Florida, United States
In-Quest Medical Research, Llc
🇺🇸Duluth, Georgia, United States
Ocean Blue Medical Research Center, Inc.
🇺🇸Miami Springs, Florida, United States
River Birch Research Alliance, Llc
🇺🇸Blue Ridge, Georgia, United States
Hci-Metromedic Walk-In Medical Office
🇺🇸New Bedford, Massachusetts, United States
Baptist Diabetes Associates, Pa
🇺🇸Miami, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
South Miami Clinical Research, Llc
🇺🇸South Miami, Florida, United States
American Health Network Of In Llc
🇺🇸Muncie, Indiana, United States
Genesis Clinical Research, Llc
🇺🇸Fall River, Massachusetts, United States
Middle Georgia Clinical Research Center, Llc
🇺🇸Perry, Georgia, United States
Springfield Diabetes And Endocrine Center
🇺🇸Springfield, Illinois, United States
Investigators Research Group, Llc
🇺🇸Brownsburg, Indiana, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
Laporte County Institute For Clinical Research, Inc.
🇺🇸Michigan City, Indiana, United States
Pmg Research Of Wilmington Llc
🇺🇸Wilmington, North Carolina, United States
Neurocare, Inc.
🇺🇸Brookline, Massachusetts, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Atlantic Clinical Trials, Llc
🇺🇸Watertown, Massachusetts, United States
Providence Park Clinical Research
🇺🇸Novi, Michigan, United States
Office Of Ted Thorp, Md
🇺🇸Las Vegas, Nevada, United States
Research Across America
🇺🇸Reading, Pennsylvania, United States
Southgate Medical Group
🇺🇸West Seneca, New York, United States
Joslin Diabetes Center Affiliate Of Snhmc
🇺🇸Nashua, New Hampshire, United States
Barat Research Group, Inc.
🇺🇸Charlotte, North Carolina, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
Premier Internal Medicine
🇺🇸Memphis, Tennessee, United States
Fanno Creek Clinic
🇺🇸Portland, Oregon, United States
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
Southeastern Pa Medical Institute
🇺🇸Broomall, Pennsylvania, United States
Exodus Healthcare Network
🇺🇸Magna, Utah, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Chattanooga Research & Medicine, Pllc
🇺🇸Chattanooga, Tennessee, United States
Sergio F. Rovner, M.D.
🇺🇸El Paso, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Sugarland, Texas, United States
North Hills Medical Research, Inc.
🇺🇸North Richland Hills, Texas, United States
Lisa E. Medwedeff, Md, Pa
🇺🇸Plano, Texas, United States
Millennium Clinical Trials Llc
🇺🇸Arlington, Virginia, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Sound Medical Research
🇺🇸Port Orchard, Washington, United States
Quality Control Research, Inc
🇺🇸Sacramento, California, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Compass Research, Llc
🇺🇸Orlando, Florida, United States
Florida Institute For Clinical Research, Llc
🇺🇸Orlando, Florida, United States