Diabetes Clinical Trial
Official title:
Replication of Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS Trial)
Verified date | July 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Status | Completed |
Enrollment | 152202 |
Est. completion date | February 18, 2021 |
Est. primary completion date | February 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Eligible cohort entry dates: 4/1/2013-12/31/2016 (market availability of sitagliptin in the U.S. started on 10/17/2006). For Optum, 4/1/2013-9/30/2017. Inclusion Criteria: - Man or woman with a diagnosis of type 2 diabetes with glycated hemoglobin level =7.0% to=10.5% at screening and be either 1. not currently on antihyperglycemic agent (AHA) therapy or 2. on AHA monotherapy or combination therapy with any approved class of agents: e.g., sulfonylurea, metformin, peroxisome proliferator-activated receptor gamma (PPAR?) agonist, alpha-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1) analogue, dipeptidyl peptidase-4 (DPP-4) inhibitor, or insulin. - Age =30 years with documented symptomatic atherosclerotic cardiovascular disease - Age =50 years with 2 or more of the following risk factors determined at the screening visit Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. - History of one or more severe hypoglycemic episode within 6 months before screening - Ongoing, inadequately controlled thyroid disorder. - Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant. - MI, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening, or a planned revascularization procedure, or history of New York Heart Association (NYHA) Class IV cardiac disease. - Findings on 12-lead electrocardiogram (ECG) that would require urgent diagnostic evaluation or intervention - History of hepatitis B surface antigen or hepatitis C antibody positive - Any history of or planned bariatric surgery. - History of malignancy within 5 years before screening - History of human immunodeficiency virus (HIV) antibody positive. - Subject has a current clinically important hematological disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia). - Major surgery (i.e., requiring general anesthesia) within 3 months of the screening visit or any surgery planned during the subject's expected participation in the study - Current use of other sodium glucose co-transporter 2 (SGLT2) inhibitor. - Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication |
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relative hazard of composite outcome of Stroke, MI, and Mortality | Relative hazard of composite outcome of MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations. | Through study completion (a median of 120-140 days) |
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