Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
NCT ID: NCT01042977
Last Updated: 2014-02-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
964 participants
INTERVENTIONAL
2010-03-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
NCT00673231
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
NCT01392677
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01646320
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
NCT00736879
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
NCT00831779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
dapagliflozin 10 mg tablet
Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
2
matching placebo tablet
Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cardiovascular disease
* Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Lawrence A Leiter, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Endocrinology & Metabolism, St Michael's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Bell Gardens, California, United States
Research Site
Chino, California, United States
Research Site
Chula Vista, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Mission Hills, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Torrance, California, United States
Research Site
Aventura, Florida, United States
Research Site
Boca Raton, Florida, United States
Research Site
Bradenton, Florida, United States
Research Site
Brooksville, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Dania Beach, Florida, United States
Research Site
Delray Beach, Florida, United States
Research Site
New Smyrna Beach, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Springfield, Illinois, United States
Research Site
Avon, Indiana, United States
Research Site
Franklin, Indiana, United States
Research Site
Greenfield, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
Waterloo, Iowa, United States
Research Site
Topeka, Kansas, United States
Research Site
Paducah, Kentucky, United States
Research Site
Alexandria, Louisiana, United States
Research Site
Rockville, Maryland, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Livonia, Michigan, United States
Research Site
Billings, Montana, United States
Research Site
Berlin, New Jersey, United States
Research Site
Brick, New Jersey, United States
Research Site
Asheboro, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Altoona, Pennsylvania, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Holland, Pennsylvania, United States
Research Site
Lancaster, Pennsylvania, United States
Research Site
Media, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Irving, Texas, United States
Research Site
Richardson, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sugarland, Texas, United States
Research Site
Alexandria, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Buenos Aires, Buenos Aires F.D., Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Salta, Salta Province, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
Blacktown, New South Wales, Australia
Research Site
Broadmeadow, New South Wales, Australia
Research Site
Hornsby, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
Kippa-Ring, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Bedford Park, South Australia, Australia
Research Site
Keswick, South Australia, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Heidelberg, Victoria, Australia
Research Site
Herston, , Australia
Research Site
Vienna, , Austria
Research Site
Blagoevgrad, , Bulgaria
Research Site
Pernik, , Bulgaria
Research Site
Pleven, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sevlievo, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Thornhill, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Mirabel, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Santiago, Santiago Metropolitan, Chile
Research Site
Damme, , Germany
Research Site
Dortmund, , Germany
Research Site
Homburg, , Germany
Research Site
Münster, , Germany
Research Site
Wangen, , Germany
Research Site
Ajka, , Hungary
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Esztergom, , Hungary
Research Site
Győr, , Hungary
Research Site
Komárom, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Tát, , Hungary
Research Site
Veszprém, , Hungary
Research Site
Bialystok, , Poland
Research Site
Chrzanów, , Poland
Research Site
Gdansk, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Iława, , Poland
Research Site
Kielce, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Mrągowo, , Poland
Research Site
Nowy Sącz, , Poland
Research Site
Poznan, , Poland
Research Site
Płock, , Poland
Research Site
Ruda Śląska, , Poland
Research Site
Skierniewice, , Poland
Research Site
Sopot, , Poland
Research Site
Tarnów, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zabrze, , Poland
Research Site
Zgierz, , Poland
Research Site
Zielona Góra, , Poland
Research Site
Łęczna, , Poland
Research Site
Łęczyca, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1690C00019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.