AzTrials
AzTrials

Type 2 DiabetesPhase 3NCT01195662

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

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 298 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment… 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
2,245 participants
Where
298 sitesin 16 countries
Study dates
Oct 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

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

Who cannot join

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

Trial locations and contacts

298 sites in 16 countries.

298 sites in 16 countries

United States155 sites

  • Alexandria Health Care Center

    Alexandria, Virginia, 22314

  • Cmp Research

    Anaheim, California, 92805

  • Arlington Family Research Center, Inc.

    Arlington, Texas, 76012

  • Millennium Clinical Trials Llc

    Arlington, Virginia, 22203

  • Perimeter Institute For Clinical Research

    Atlanta, Georgia, 30338

  • 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

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • 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

  • 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

  • Medical Research South

    Charleston, South Carolina, 29407

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Catalina Research Institute, Llc

    Chino, California, 91710

  • Community Research

    Cincinnati, Ohio, 45227

  • Innovative Research Of West Florida, Inc

    Clearwater, Florida, 33756

  • Parsons Avenue Medical Clinical

    Columbus, Ohio, 43207

  • Clinical Research Of South Florida

    Coral Gables, Florida, 33134

  • 3rd Coast Research Associates

    Corpus Christi, Texas, 78414

  • Krk Medical Research

    Dallas, Texas, 75230

  • Research Institute Of Dallas

    Dallas, Texas, 75231

  • Internal Medicine Clinical Reaseach

    Dallas, Texas, 75235

  • Renaissance Clinical Research And Hypertension Pllc

    Dallas, Texas, 75235

  • Avail Clinical Research, Llc

    DeLand, Florida, 32720

  • In-Quest Medical Research, Llc

    Duluth, Georgia, 30096

  • Sergio F. Rovner, M.D.

    El Paso, Texas, 79925

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Lillestol Research

    Fargo, North Dakota, 58103

  • Abington Memorial Hos/Feasterville Family Health Care Center

    Feasterville, Pennsylvania, 19053

  • Larry D. Stonesifer, Md

    Federal Way, Washington, 98003

  • 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

  • Southeastern Research Associates, Inc.

    Greenville, South Carolina, 29605

  • Clin Research Advantage, Inc. James Meli, Do Family Pracice

    Henderson, Nevada, 89014

  • International Research Associates, Llc

    Hialeah, Florida, 33012

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • The Community Research Of South Florida

    Hialeah, Florida, 33016

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77008

  • Village Family Practice

    Houston, Texas, 77024

  • Dependable Clinical Research, Llc

    Houston, Texas, 77074

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Bellaire Medical Care Group

    Houston, Texas, 77081

  • Excel Clinical Research, Llc

    Houston, Texas, 77081

  • Del Rosario Medical Clinic, Inc.

    Huntington Park, California, 90255

  • Time Clinical Research Inc.

    Huntington Park, California, 90255

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • 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, Missouri, 64106

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53142

  • Central Florida Internists

    Kissimmee, Florida, 34741

  • 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

  • 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

  • Mcs Clinical Trials

    Los Angeles, California, 90057

  • National Research Inst

    Los Angeles, California, 90057

  • Exodus Healthcare Network

    Magna, Utah, 84044

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Southwind Medical Specialists

    Memphis, Tennessee, 38125

  • Omega Clinical Research, Llc

    Metairie, Louisiana, 70006

  • Flcri Global Research, Llc

    Miami, Florida, 33125

  • Clinical Research Of Miami, Inc.

    Miami, Florida, 33126

  • Pharmax Research Clinic, Inc.

    Miami, Florida, 33126

  • Apf Research, Llc

    Miami, Florida, 33135

  • Community Research Foundation, Inc.

    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

  • Wilmax Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • American Health Network Of In Llc

    Muncie, Indiana, 47304

  • 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

  • Christiana Care Health Services, Inc

    Newark, Delaware, 19713

  • Neurocare, Inc.

    Newton, Massachusetts, 02459

  • Digiovanna Institute For Medical Education & Research

    North Massapequa, New York, 11758

  • North Myrtle Beach Family Practice

    North Myrtle Beach, South Carolina, 29582

  • 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

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Sds Clinical Trials

    Orange, California, 92868

  • Florida Institute For Clinical Research, Llc

    Orlando, Florida, 32822

  • Bayview Research Group, Llc

    Paramount, California, 90723

  • Med-Olam Clinical Research

    Pasadena, Texas, 77504

  • Pawleys Pediatrics And Adult Medicine

    Pawleys Island, South Carolina, 29585

  • Michele A. Morrison Internal Medicine, Inc.

    Pembroke Pines, Florida, 33026

  • Middle Georgia Drug Study 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

  • 43rd Medical Associates

    Phoenix, Arizona, 85051

  • Lisa E. Medwedeff, Md, Pa

    Plano, Texas, 75024

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • San Diego Managed Care Group

    Poway, California, 92064

  • Research Across America

    Reading, Pennsylvania, 19606

  • Integrated Research Group, Inc.

    Riverside, California, 92506

  • 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

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Wetlin Research Associates, Inc.

    San Diego, California, 92120

  • Crest Clinical Trials, Inc.

    Santa Ana, California, 92701

  • Neurological Research Institute

    Santa Monica, California, 90404

  • 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

  • Tn Medical Research

    Spring Hill, Tennessee, 37174

  • Springfield Diabetes And Endocrine Center

    Springfield, Illinois, 62704

  • Hampton Roads Center For Clinical Research, Inc.

    Suffolk, Virginia, 23435

  • Breco Research, Ltd

    Sugarland, Texas, 77479

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Meridien Research

    Tampa, Florida, 33606

  • Central Phoenix Medical Center

    Tempe, Arizona, 85282

  • Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc

    Tempe, Arizona, 85282

  • Clinical Research Advantage/Desert Clinical Research

    Tempe, Arizona, 85282

  • Torrance Clinical Research

    Torrance, California, 90505

  • 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

  • Greater Providence Clinical Research, Llc

    Warwick, Rhode Island, 02888

  • Chase Medical Research, Llc

    Waterbury, Connecticut, 06708

  • Atlantic Clinical Trials, Llc

    Watertown, Massachusetts, 02472

  • Southgate Medical Group

    West Seneca, New York, 14224

  • Integris Family Care Yukon

    Yukon, Oklahoma, 73099

Other trials in United States

Poland24 sites

  • Local Institution

    Bialystok, 15-404

  • Local Institution

    Bialystok, 15-879

  • Local Institution

    Chrzanów, 32-500

  • Local Institution

    Elblag, 82-300

  • Local Institution

    Gdansk, 80-847

  • Local Institution

    Gdynia, Gdynia, 81-384

  • Local Institution

    Kamieniec Ząbkowicki, 57-230

  • Local Institution

    Katowice, 40-748

  • Local Institution

    Kielce, 25-364

  • Local Institution

    Krakow, 30-015

  • Local Institution

    Krakow, 31-159

  • Local Institution

    Lodz, 90-242

  • Local Institution

    Lodz, 92-525

  • Local Institution

    Lublin, 20-044

  • Local Institution

    Ostróda, 14-100

  • Local Institution

    Poznan, 61-251

  • Local Institution

    Warsaw, 01-192

  • Local Institution

    Warsaw, 01-337

  • Local Institution

    Warsaw, 01-868

  • Local Institution

    Warsaw, 02-097

  • Local Institution

    Warsaw, 02-507

  • Local Institution

    Wroclaw, 50-088

  • Local Institution

    Wroclaw, 50-349

  • Local Institution

    Zabrze, 41-800

Other trials in Poland

India19 sites

  • Local Institution

    Bangalore, Karnataka, 560 043

  • Local Institution

    Bangalore, Karnataka, 560043

  • Local Institution

    Bangalore, Karnataka, 560092

  • Local Institution

    Belagavi, Karnatka, 590010

  • Local Institution

    Chennai, Tamil Nadu, 600013

  • Local Institution

    Chennai Tamilnadu, 6000081

  • Local Institution

    Coimbatore, Tamil Nadu, 641 018

  • Local Institution

    Delhi, New Delhi, 110007

  • Local Institution

    Hyderabad, Andhra Pradesh, 5000 18

  • Local Institution

    Hyderabad, 500063

  • Local Institution

    Indore, Madhya Pradesh, 452010

  • Local Institution

    Jaipur, Rajasthan, 202023

  • Local Institution

    Madurai, Tamil Nadu, 625020

  • Local Institution

    Mangalore, Karnataka, 575001

  • Local Institution

    Nagpur, Maharashtra, 440010

  • Local Institution

    Nagpur, Maharashtra, 440012

  • Local Institution

    Nagpur, Maharashtra, 440033

  • Local Institution

    Nagpur, 440012

  • Local Institution

    Trivandrum, 695011

Other trials in India

Germany17 sites

  • Local Institution

    Aschaffenburg, Bavaria, 63739

  • Local Institution

    Augsburg, Bavaria, 86150

  • Local Institution

    Bad Kreuznach, 55545

  • Local Institution

    Berlin, 10787

  • Local Institution

    Dortmund, 44137

  • Local Institution

    Dresden, 01307

  • Local Institution

    Duisburg, North Rhine-Westphalia, 47051

  • Local Institution

    Karlsruhe, 76199

  • Local Institution

    Köthen, 06366

  • Local Institution

    Kronshagen, 24119

  • Local Institution

    Langenfeld, 40764

  • Local Institution

    Lüneburg, 21339

  • Local Institution

    Magdeburg, 39112

  • Local Institution

    Mainz, 55116

  • Local Institution

    Mannheim, 68161

  • Local Institution

    Saarbrücken, 66121

  • Local Institution

    Wüstensachsen, 36115

Other trials in Germany

Mexico16 sites

  • Local Institution

    Chihuahua City, Chihuahua, 31217

  • Local Institution

    Cuautla, Morelos, 62744

  • Local Institution

    Culiacán, Sinaloa, 80020

  • Local Institution

    Del. Benito Juarez, 03100

  • Local Institution

    Distrito Federal, Mexico City, 07020

  • Local Institution

    Guadalajara, Jalisco, 44100

  • Local Institution

    Guadalajara, Jalisco, 44130

  • Local Institution

    Guadalajara, Jalisco, 44670

  • Local Institution

    Mérida, Yucatán, 97070

  • Local Institution

    Mexico City, Mexico City, 03300

  • Local Institution

    Mexico City, Mexico City, 07760

  • Local Institution

    Monterrey, Nuevo León, 64000

  • Local Institution

    Monterrey, Nuevo León, 64460

  • Local Institution

    San Luis Potosí City, San Luis Potosí, 78200

  • Local Institution

    Tlalpan, Mexico City, 14000

  • Local Institution

    Torreón, Coahuila, 27000

Other trials in Mexico

Romania16 sites

  • Local Institution

    Bucharest, 010507

  • Local Institution

    Bucharest, 010719

  • Local Institution

    Bucharest, 020475

  • Local Institution

    Bucharest, 020725

  • Local Institution

    Cluj-Napoca, 400006

  • Local Institution

    Oradea, Bihor County, 410169

  • Local Institution

    Oradea, Jud. Bihor, 410469

  • Local Institution

    Ploieşti, Prahova, 100163

  • Local Institution

    Ploieşti, Prahova, 100342

  • Local Institution

    Satu Mare, Satu Mare County, 440055

  • Local Institution

    Sibiu, Sibiu County, 550371

  • Local Institution

    Sibiu, 550245

  • Local Institution

    Târgu Mureş, Mureș County, 540098

  • Local Institution

    Târgu Mureş, Mureș County, 540142

  • Local Institution

    Timișoara, Jud. Timis, 300125

  • Local Institution

    Timișoara, Timiș County, 300456

Other trials in Romania

Hungary11 sites

  • Local Institution

    Budapest, 1134

  • Local Institution

    Budapest, H-1171

  • Local Institution

    Eger, 3300

  • Local Institution

    Gyöngyös, Heves County, 3200

  • Local Institution

    Kisvárda, 4600

  • Local Institution

    Miskolc, 3530

  • Local Institution

    Nyíregyháza, 4400

  • Local Institution

    Sátoraljaújhely, 3980

  • Local Institution

    Sopron, 9400

  • Local Institution

    Szeged, 6720

  • Local Institution

    Szekszárd, H-7100

Other trials in Hungary

Czechia8 sites

  • Local Institution

    Beroun, 266 01

  • Local Institution

    Cheb, 350 02

  • Local Institution

    Havířov, 736 01

  • Local Institution

    Krnov, 794 01

  • Local Institution

    Liberec, 460 01

  • Local Institution

    Ostrava, 702 00

  • Local Institution

    Prague, 116 94

  • Local Institution

    Prague, 149 00

Other trials in Czechia

Canada7 sites

  • Local Institution

    Brampton, Ontario, L6T 3J1

  • Local Institution

    Granby, Quebec, J2G 8Z9

  • Local Institution

    Kelowona, British Columbia, V1Y 3G8

  • Local Institution

    Monction, New Brunswick, E1G 1A7

  • Local Institution

    Montreal, Quebec, H2R 1V6

  • Local Institution

    Saskatoon, Saskatchewan, S7K 3H3

  • Local Institution

    Victoria, British Columbia, V8V 3N7

Other trials in Canada

Colombia5 sites

  • Local Institution

    Armenia, Quindío Department, 0000

  • Local Institution

    Barranquilla, 0000

  • Local Institution

    Barranquilla

  • Local Institution

    Bogotá, 0000

  • Local Institution

    Bucaramanga, Santander Department, 0000

Other trials in Colombia

Denmark4 sites

  • Local Institution

    Copenhagen, DK 2400

  • Local Institution

    Frederiksberg, 2000

  • Local Institution

    Gentofte Municipality, 2820

  • Local Institution

    Slagelse, 4200

Other trials in Denmark

Finland4 sites

  • Local Institution

    Helsinki, 09200

  • Local Institution

    Kerava, 04200

  • Local Institution

    Kokkola, 67100

  • Local Institution

    Oulu, 90100

Other trials in Finland

United Kingdom4 sites

  • Local Institution

    Bath, Wiltshire, BA2 3HT

  • Local Institution

    Birmingham, West Midlands, B9 5SS

  • Local Institution

    Ely, Cambridgeshire, CB7 5JD

  • Local Institution

    Irvine, Ayrshire, KA11 1JU

Other trials in United Kingdom

Australia3 sites

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Heidelberg, Victoria, 3081

  • Local Institution

    Nedlands, Western Australia, 6009

Other trials in Australia

Puerto Rico3 sites

  • Local Institution

    Fajard, 00738

  • Local Institution

    Ponce, 00717

  • Local Institution

    San Juan, 00920

Other trials in Puerto Rico

Ireland2 sites

  • Local Institution

    Dublin, Dublin

  • Local Institution

    Galway

Other trials in Ireland

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

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

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 Inhibitors, Angiotensin-Converting Enzyme Inhibitors, Antihypertensive Agents, Cardiovascular Agents, Pharmacological Actions
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, Farxiga™

    Tablets, Oral, 10 mg, once daily, Up to 12 weeks

  • Placebo matching DapagliflozinDrug

    Tablets, Oral, 0 mg, once daily, Up to 12 weeks

Study groups in NCT01195662
Study groupRoleWhat they receive
Dapagliflozin 10 mgExperimentalDapagliflozin 10 mg tablets
Receives: Drug: Dapagliflozin
Placebo matching DapagliflozinPlacebo comparatorPlacebo tablets matching dapagliflozin tablets
Receives: Drug: Placebo matching Dapagliflozin

What is being measured

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

  1. Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants

    Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.

    Measured: Baseline to Week 12

  2. Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants

    Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.

    Measured: Baseline to Week 12

Secondary outcomes (9)

  1. Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)

    Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.

    Measured: Baseline, Week 12

  2. Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants

    Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.

    Measured: Baseline to Week 12

  3. Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)

    Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.

    Measured: Baseline, Week 12

  4. Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants

    Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.

    Measured: Baseline, Week 12

  5. Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue

    Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.

    Measured: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event

  6. Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue

    Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.

    Measured: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days

  7. Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue

    Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.

    Measured: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days

  8. Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue

    12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.

    Measured: Baseline, Week 12

  9. Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue

    Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.

    Measured: Baseline (Day 1), Week 12

Timeline

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

  1. First posted6 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
2,245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01195662
Sponsor's protocol ID
MB102-077 ST
Other IDs
2010-019798-13
Status last verified
Dec 2015
First submitted
3 Sep 2010
Last updated
29 Dec 2016
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

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

    PubMed 26620248

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 298 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 7 inclusion and 6 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 298 sites in United States, Poland, India, Germany, Mexico 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 23 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 for 12 Week Double-Blind Treatment Period - Randomized Participants (time frame: 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 NCT01195662, which also lists 2 linked publications.

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 29 Dec 2016.

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