Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
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
1 other identifier
interventional
964
9 countries
123
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Mar 2010
Longer than P75 for phase_3 type-2-diabetes-mellitus
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 23, 2013
CompletedFebruary 17, 2014
December 1, 2013
1.2 years
January 5, 2010
January 21, 2013
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adjusted Mean Change in HbA1c Levels
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.
Baseline to Week 24
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Baseline to Week 24
Secondary Outcomes (5)
Adjusted Mean Percent Change in Body Weight
Baseline to Week 24
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
Baseline to Week 24
Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)
Baseline to Week 8
Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)
Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg
Baseline to Week 8
Study Arms (2)
1
EXPERIMENTALdapagliflozin 10 mg tablet
2
PLACEBO COMPARATORmatching placebo tablet
Interventions
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (135)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Anaheim, California, United States
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Bell Gardens, California, United States
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Chino, California, United States
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Chula Vista, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Redondo Beach, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Dania Beach, Florida, United States
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Delray Beach, Florida, United States
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New Smyrna Beach, Florida, United States
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Orlando, Florida, United States
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Springfield, Illinois, United States
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Avon, Indiana, United States
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Franklin, Indiana, United States
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Greenfield, Indiana, United States
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Muncie, Indiana, United States
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Waterloo, Iowa, United States
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Topeka, Kansas, United States
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Paducah, Kentucky, United States
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Alexandria, Louisiana, United States
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Rockville, Maryland, United States
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Kalamazoo, Michigan, United States
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Livonia, Michigan, United States
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Billings, Montana, United States
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Berlin, New Jersey, United States
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Brick, New Jersey, United States
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Asheboro, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Holland, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Alexandria, Virginia, United States
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Manassas, Virginia, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Blacktown, New South Wales, Australia
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Broadmeadow, New South Wales, Australia
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Hornsby, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Herston, Australia
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Vienna, Austria
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Blagoevgrad, Bulgaria
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Pernik, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Moncton, New Brunswick, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Etobicoke, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, Santiago Metropolitan, Chile
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Damme, Germany
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Dortmund, Germany
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Homburg, Germany
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Münster, Germany
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Wangen, Germany
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Ajka, Hungary
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Balatonfüred, Hungary
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Budapest, Hungary
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Esztergom, Hungary
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Győr, Hungary
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Komárom, Hungary
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Mosonmagyaróvár, Hungary
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Tát, Hungary
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Veszprém, Hungary
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Bialystok, Poland
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Chrzanów, Poland
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Gdansk, Poland
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Grodzisk Mazowiecki, Poland
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Iława, Poland
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Kielce, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Mrągowo, Poland
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Nowy Sącz, Poland
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Poznan, Poland
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Płock, Poland
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Ruda Śląska, Poland
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Skierniewice, Poland
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Sopot, Poland
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Tarnów, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Zgierz, Poland
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Zielona Góra, Poland
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Łęczna, Poland
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Łęczyca, Poland
Related Publications (1)
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.
PMID: 38770818DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Lawrence A Leiter, MD
Division of Endocrinology & Metabolism, St Michael's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
March 1, 2010
Primary Completion
May 1, 2011
Study Completion
December 1, 2012
Last Updated
February 17, 2014
Results First Posted
August 23, 2013
Record last verified: 2013-12