Clinical trial NCT01195662: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-09-06
Enrollment: 2245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
timeFrame: Baseline to Week 12
measure: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12
measure: Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants
timeFrame: Baseline to Week 12
measure: Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)
timeFrame: Baseline, Week 12
measure: Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event
measure: Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue
timeFrame: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days
measure: Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue
timeFrame: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days
measure: Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue
timeFrame: Baseline, Week 12
measure: Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue
timeFrame: Baseline (Day 1), Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Mobile
country: United States
facility: Wilmax Clinical Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: 43rd Medical Associates
state: Arizona
city: Tempe
country: United States
facility: Central Phoenix Medical Center
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage/Desert Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Aureus Research, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Cmp Research
state: California
city: Chino
country: United States
facility: Catalina Research Institute, Llc
state: California
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Huntington Park
country: United States
facility: Del Rosario Medical Clinic, Inc.
state: California
city: Huntington Park
country: United States
facility: Time Clinical Research Inc.
state: California
city: Los Angeles
country: United States
facility: Clinica Medica San Miguel
state: California
city: Los Angeles
country: United States
facility: American Institute Of Research
state: California
city: Los Angeles
country: United States
facility: Randall G. Shue, D.O.
state: California
city: Los Angeles
country: United States
facility: Mcs Clinical Trials
state: California
city: Los Angeles
country: United States
facility: National Research Inst
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz,Md.,Inc.
state: California
city: Orange
country: United States
facility: Sds Clinical Trials
state: California
city: Paramount
country: United States
facility: Bayview Research Group, Llc
state: California
city: Poway
country: United States
facility: San Diego Managed Care Group
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Inc.
state: California
city: Sacramento
country: United States
facility: Quality Control Research, Inc
state: California
city: San Diego
country: United States
facility: Wetlin Research Associates, Inc.
state: California
city: Santa Ana
country: United States
facility: Crest Clinical Trials, Inc.
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Santa Monica
country: United States
facility: Orrin M. Troum, Md And Medical Associates
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, Llc
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services, Inc
state: Delaware
city: Boynton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Clearwater
country: United States
facility: Innovative Research Of West Florida, Inc
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research Of South Florida
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, Llc
state: Florida
city: Hialeah
country: United States
facility: International Research Associates, Llc
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Hialeah
country: United States
facility: The Community Research Of South Florida
state: Florida
city: Kissimmee
country: United States
facility: Central Florida Internists
state: Florida
city: Miami Beach
country: United States
facility: Newphase Clinical Trials, Inc.
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Flcri Global Research, Llc
state: Florida
city: Miami
country: United States
facility: Clinical Research Of Miami, Inc.
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Apf Research, Llc
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc.
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates, Pa
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research, Llc
state: Florida
city: Pembroke Pines
country: United States
facility: Michele A. Morrison Internal Medicine, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute For Clinical Research
state: Georgia
city: Bainbridge
country: United States
facility: Bainbridge Medical Associates
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, Llc
state: Georgia
city: Duluth
country: United States
facility: In-Quest Medical Research, Llc
state: Georgia
city: Perry
country: United States
facility: Middle Georgia Drug Study Center, Llc
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: O?Fallon
country: United States
facility: So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
state: Illinois
city: Springfield
country: United States
facility: Springfield Diabetes And Endocrine Center
state: Illinois
city: Avon
country: United States
facility: American Health Network Of Indiana Llc
state: Indiana
city: Brownsburg
country: United States
facility: Investigators Research Group, Llc
state: Indiana
city: Franklin
country: United States
facility: American Health Network Of In Llc
state: Indiana
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research, Inc.
state: Indiana
city: Muncie
country: United States
facility: American Health Network Of In Llc
state: Indiana
city: Baton Rouge
country: United States
facility: Medical Development Centers, Llc
state: Louisiana
city: Metairie
country: United States
facility: Omega Clinical Research, Llc
state: Louisiana
city: Bangor
country: United States
facility: Acadia Clinical Research, Llc
state: Maine
city: Silver Spring
country: United States
facility: Alternative Primary Care
state: Maryland
city: New Bedford
country: United States
facility: Hci-Metromedic Walk-In Medical Office
state: Massachusetts
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Atlantic Clinical Trials, Llc
state: Massachusetts
city: Novi
country: United States
facility: Providence Park Clinical Research
state: Michigan
city: Biloxi
country: United States
facility: The Center For Clinical Trials
state: Mississippi
city: Jackson
country: United States
facility: Phillips Medical Services, Pllc
state: Mississippi
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Kansas City
country: United States
facility: Kcumb Dybedal Clinical Research Center
state: Missouri
city: Henderson
country: United States
facility: Clin Research Advantage, Inc. James Meli, Do Family Pracice
state: Nevada
city: Las Vegas
country: United States
facility: Office Of Ted Thorp, Md
state: Nevada
city: Las Vegas
country: United States
facility: Independent Clinical Researchers@ Wolfson Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Palm Medical Research Center
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: North Massapequa
country: United States
facility: Digiovanna Institute For Medical Education & Research
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Canal Fulton
country: United States
facility: Community Health Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbus
country: United States
facility: Parsons Avenue Medical Clinical
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Yukon
country: United States
facility: Integris Family Care Yukon
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Broomall
country: United States
facility: Southeastern Pa Medical Institute
state: Pennsylvania
city: Feasterville
country: United States
facility: Abington Memorial Hos/Feasterville Family Health Care Center
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arcuri Clinical Research Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Health Associates - Adult Medicine
state: Pennsylvania
city: Reading
country: United States
facility: Research Across America
state: Pennsylvania
city: Uniontown
country: United States
facility: Pish Medical Associates
state: Pennsylvania
city: Warwick
country: United States
facility: Greater Providence Clinical Research, Llc
state: Rhode Island
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Greenville
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: North Myrtle Beach
country: United States
facility: North Myrtle Beach Family Practice
state: South Carolina
city: Pawleys Island
country: United States
facility: Pawleys Pediatrics And Adult Medicine
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Reseach, Llc
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Memphis
country: United States
facility: Southwind Medical Specialists
state: Tennessee
city: Spring Hill
country: United States
facility: Tn Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Arlington Family Research Center, Inc.
state: Texas
city: Corpus Christi
country: United States
facility: 3rd Coast Research Associates
state: Texas
city: Dallas
country: United States
facility: Krk Medical Research
state: Texas
city: Dallas
country: United States
facility: Research Institute Of Dallas
state: Texas
city: Dallas
country: United States
facility: Internal Medicine Clinical Reaseach
state: Texas
city: Dallas
country: United States
facility: Renaissance Clinical Research And Hypertension Pllc
state: Texas
city: El Paso
country: United States
facility: Sergio F. Rovner, M.D.
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Houston
country: United States
facility: Village Family Practice
state: Texas
city: Houston
country: United States
facility: Dependable Clinical Research, Llc
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Bellaire Medical Care Group
state: Texas
city: Houston
country: United States
facility: Excel Clinical Research, Llc
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research, Inc.
state: Texas
city: Pasadena
country: United States
facility: Med-Olam Clinical Research
state: Texas
city: Plano
country: United States
facility: Lisa E. Medwedeff, Md, Pa
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Abbott Clinical Research Group, Inc.
state: Texas
city: San Antonio
country: United States
facility: Covenant Clinical Research, Pa
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Sugarland
country: United States
facility: Breco Research, Ltd
state: Texas
city: Magna
country: United States
facility: Exodus Healthcare Network
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Endocrinology And Diabetes Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Alexandria
country: United States
facility: Alexandria Health Care Center
state: Virginia
city: Arlington
country: United States
facility: Millennium Clinical Trials Llc
state: Virginia
city: Burke
country: United States
facility: Burke Internal Medicine And Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Suffolk
country: United States
facility: Hampton Roads Center For Clinical Research, Inc.
state: Virginia
city: Federal Way
country: United States
facility: Larry D. Stonesifer, Md
state: Washington
city: Port Orchard
country: United States
facility: Sound Medical Research
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Kelowona
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Monction
country: Canada
facility: Local Institution
state: New Brunswick
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Granby
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Armenia
country: Colombia
facility: Local Institution
state: Quindio
city: Bucaramanga
country: Colombia
facility: Local Institution
state: Santander
city: Barranquilla
country: Colombia
facility: Local Institution
city: Barranquilla
country: Colombia
facility: Local Institution
city: Bogota
country: Colombia
facility: Local Institution
city: Beroun
country: Czech Republic
facility: Local Institution
city: Cheb
country: Czech Republic
facility: Local Institution
city: Havirov
country: Czech Republic
facility: Local Institution
city: Krnov
country: Czech Republic
facility: Local Institution
city: Liberec
country: Czech Republic
facility: Local Institution
city: Ostrava
country: Czech Republic
facility: Local Institution
city: Prague 1
country: Czech Republic
facility: Local Institution
city: Praha 4
country: Czech Republic
facility: Local Institution
city: Copenhagen
country: Denmark
facility: Local Institution
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Gentofte
country: Denmark
facility: Local Institution
city: Slagelse
country: Denmark
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution
city: Kerava
country: Finland
facility: Local Institution
city: Kokkola
country: Finland
facility: Local Institution
city: Oulu
country: Finland
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
state: Bavaria
city: Augsburg
country: Germany
facility: Local Institution
state: Bavaria
city: Duisburg
country: Germany
facility: Local Institution
state: Nordrhein-Westfalen
city: Bad Kreuznach
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Dortmund
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Karlsruhe
country: Germany
facility: Local Institution
city: Kothen
country: Germany
facility: Local Institution
city: Kronshagen
country: Germany
facility: Local Institution
city: Langenfeld
country: Germany
facility: Local Institution
city: Lueneburg
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Saarbruecken
country: Germany
facility: Local Institution
city: Wuestensachsen
country: Germany
facility: Local Institution
city: Gyongyos
country: Hungary
facility: Local Institution
state: Heves
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Eger
country: Hungary
facility: Local Institution
city: Kisvarda
country: Hungary
facility: Local Institution
city: Miskolc
country: Hungary
facility: Local Institution
city: Nyiregyhaza
country: Hungary
facility: Local Institution
city: Satoraljaujhely
country: Hungary
facility: Local Institution
city: Sopron
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Szekszard
country: Hungary
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Mangalore
country: India
facility: Local Institution
state: Karnataka
city: Belgaum
country: India
facility: Local Institution
state: Karnatka
city: Indore
country: India
facility: Local Institution
state: Madhya Pradesh
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution
state: Maharashtra
city: Delhi
country: India
facility: Local Institution
state: New Delhi
city: Jaipur
country: India
facility: Local Institution
state: Rajasthan
city: Chennai
country: India
facility: Local Institution
state: Tamil Nadu
city: Coimbatore
country: India
facility: Local Institution
state: Tamil Nadu
city: Madurai
country: India
facility: Local Institution
state: Tamilnadu
city: Chennai Tamilnadu
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Nagpur
country: India
facility: Local Institution
city: Trivandrum
country: India
facility: Local Institution
city: Dublin 15
country: Ireland
facility: Local Institution
state: Dublin
city: Galway
country: Ireland
facility: Local Institution
city: Torreon
country: Mexico
facility: Local Institution
state: Coahuila
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuautla
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Culiacan
country: Mexico
facility: Local Institution
state: Sinaloa
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Chihuahua
country: Mexico
facility: Local Institution
city: Del. Benito Juarez
country: Mexico
facility: Local Institution
city: Delegacion Tlalpan
country: Mexico
facility: Local Institution
city: Distrito Federal
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Chrzanow
country: Poland
facility: Local Institution
city: Elblag
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Gdynia
country: Poland
facility: Local Institution
city: Kamieniec Zabkowicki
country: Poland
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Ostroda
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Zabrze
country: Poland
facility: Local Institution
city: Fajard
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Oradea
country: Romania
facility: Local Institution
state: Bihor
city: Oradea
country: Romania
facility: Local Institution
state: Jud. Bihor
city: Timisoara
country: Romania
facility: Local Institution
state: Jud. Timis
city: Targu Mures
country: Romania
facility: Local Institution
state: Mures
city: Targu Mures
country: Romania
facility: Local Institution
state: Mures
city: Ploiesti
country: Romania
facility: Local Institution
state: Prahova
city: Ploiesti
country: Romania
facility: Local Institution
state: Prahova
city: Timisoara
country: Romania
facility: Local Institution
state: Timis
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj-Napoca
country: Romania
facility: Local Institution
city: Satu Mare
country: Romania
facility: Local Institution
city: Sibiu
country: Romania
facility: Local Institution
city: Sibiu
country: Romania
facility: Local Institution
city: Irvine
country: United Kingdom
facility: Local Institution
state: Ayrshire
city: Ely
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Bath
country: United Kingdom
facility: Local Institution
state: Wiltshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.