Clinical trial NCT01031680: Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Official title: A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Hypertension
Inadequate Glycaemic Control
Keywords: dapagliflozin
diabetes
cardiovascular disease
hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-12-14
Enrollment: 922
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus.
* Cardiovascular disease
* Hypertension

Exclusion Criteria:

* Patients with type 1 diabetes or diabetes insipidus
* Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
* Any clinically significant illness, which would compromise the patient's safety and their participation in the study

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 24
measure: Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
timeFrame: Baseline to Week 8
measure: Adjusted Mean Percent Change in Body Weight
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
timeFrame: Baseline to Week 24
measure: Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Burbank
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Lancaster
country: United States
facility: Research Site
state: California
city: Salinas
country: United States
facility: Research Site
state: California
city: San Marino
country: United States
facility: Research Site
state: California
city: San Ramon
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Deerfield Beach
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Port Charlotte
country: United States
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state: Florida
city: Port Orange
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Columbus
country: United States
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state: Georgia
city: Decatur
country: United States
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state: Georgia
city: Stone Mountain
country: United States
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state: Georgia
city: Honolulu
country: United States
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state: Hawaii
city: Chicago
country: United States
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state: Illinois
city: Wichita
country: United States
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state: Kansas
city: Baton Rouge
country: United States
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state: Louisiana
city: Lake Charles
country: United States
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state: Louisiana
city: West Monroe
country: United States
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city: Baltimore
country: United States
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state: Maryland
city: Kansas City
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state: Missouri
city: St Louis
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city: Las Vegas
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city: Brick
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city: Oradell
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city: Bronx
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city: New Hyde Park
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city: Dayton
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city: Oklahoma City
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city: Philadelphia
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state: Pennsylvania
city: Phoenixville
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city: Pittsburgh
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city: Reading
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state: South Carolina
city: Kingsport
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state: Tennessee
city: Carrollton
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state: Texas
city: Dallas
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state: Texas
city: Fort Worth
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city: Houston
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city: North Richland Hills
country: United States
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city: Plano
country: United States
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state: Texas
city: San Antonio
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city: Tomball
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city: Danville
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state: Virginia
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Research Site
state: Caba
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
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city: Mendoza
country: Argentina
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city: Santa Fe
country: Argentina
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city: Calgary
country: Canada
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state: Alberta
city: New Westminster
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Carbonear
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Lachine
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-marc-des-carrieres
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Potsdam
country: Germany
facility: Research Site
state: BR
city: Bad Nauheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Erdmannhausen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
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city: Hildesheim
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Potsdam
country: Germany
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city: Speyer
country: Germany
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city: Wahlstedt
country: Germany
facility: Research Site
city: Braila
country: Romania
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city: Brasov
country: Romania
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city: Bucharest
country: Romania
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city: Bucuresti
country: Romania
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city: Constanta
country: Romania
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city: Iasi
country: Romania
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city: Sibiu
country: Romania
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city: Suceava
country: Romania
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Komarno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kysucke Nove Mesto
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Prievidza
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
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city: Ruzomberok
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucia
city: Granada
country: Spain
facility: Research Site
state: Andalucia
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Lerida
country: Spain
facility: Research Site
state: Cataluna
city: Olot (girona)
country: Spain
facility: Research Site
state: Cataluna
city: Majadahonda
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: San Juan (alicante)
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Islas Baleares
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan County
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-yuan
country: Taiwan
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Pennington Biomedical Research Center
name: Dr. William Cefalu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.