Clinical trial NCT01042977: Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
Official title: A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Inadequate Glycaemic Control
Keywords: dapagliflozin
diabetes
cardiovascular disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-01-06
Enrollment: 964
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 improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's 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 and cardiovascular disease


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus.
* Cardiovascular disease
* Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

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 Percent Change in Body Weight
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
measure: Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)
timeFrame: Baseline to Week 8
measure: Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Bell Gardens
country: United States
facility: Research Site
state: California
city: Chino
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Hills
country: United States
facility: Research Site
state: California
city: Redondo Beach
country: United States
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state: California
city: Riverside
country: United States
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city: Sacramento
country: United States
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city: San Diego
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city: Torrance
country: United States
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city: Aventura
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city: Boca Raton
country: United States
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city: Bradenton
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city: Brooksville
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city: Clearwater
country: United States
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city: Dania
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city: Delray Beach
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city: New Smyrna Beach
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city: Orlando
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city: Avon
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city: Franklin
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city: Greenfield
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city: Muncie
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city: Waterloo
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city: Paducah
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city: Alexandria
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city: Rockville
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city: Kalamazoo
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city: Livonia
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city: Brick
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city: Fargo
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city: Cincinnati
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city: Oklahoma City
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city: Altoona
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city: Erie
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city: Corpus Christi
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city: Dallas
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state: Virginia
city: Manassas
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state: Virginia
city: Buenos Aires
country: Argentina
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state: Caba
city: Rosario
country: Argentina
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city: Cordoba
country: Argentina
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country: Argentina
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country: Argentina
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country: Australia
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state: New South Wales
city: Broadmeadow
country: Australia
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city: Hornsby
country: Australia
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city: Wollongong
country: Australia
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state: New South Wales
city: Carina Heights
country: Australia
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state: Queensland
city: Kippa-ring
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
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state: South Australia
city: Bedford Park
country: Australia
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state: South Australia
city: Keswick
country: Australia
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state: South Australia
city: Box Hill
country: Australia
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state: Victoria
city: Heidelberg
country: Australia
facility: Research Site
state: Victoria
city: Herston
country: Australia
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city: Wien
country: Austria
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city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Pernik
country: Bulgaria
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city: Pleven
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sevlievo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
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state: Ontario
city: Scarborough
country: Canada
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state: Ontario
city: Thornhill
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Mirabel
country: Canada
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state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
state: Region Metropolitana
city: Damme
country: Germany
facility: Research Site
city: Dortmund
country: Germany
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city: Homburg
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Wangen
country: Germany
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city: Ajka
country: Hungary
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city: Balatonfured
country: Hungary
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city: Budapest
country: Hungary
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city: Esztergom
country: Hungary
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city: Gyor
country: Hungary
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city: Komarom
country: Hungary
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city: Mosonmagyarovar
country: Hungary
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city: TAT
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Ilawa
country: Poland
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city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
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city: Leczna
country: Poland
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city: Leczyca
country: Poland
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city: Lodz
country: Poland
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city: Lublin
country: Poland
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city: Mragowo
country: Poland
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city: Nowy Sacz
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Tarnow
country: Poland
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city: Torun
country: Poland
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city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Zielona Gora
country: Poland
facility: Research Site
Study officials:
affiliation: Division of Endocrinology & Metabolism, St Michael's Hospital
name: Dr. Lawrence A Leiter, MD
role: PRINCIPAL_INVESTIGATOR
References: