- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936010
Replication of the CANVAS Diabetes Trial in Healthcare Claims
Replication of Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham & Women'S Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
- not currently on antihyperglycemic agent (AHA) therapy or
- on AHA monotherapy or combination therapy with any approved class of agents: e.g., sulfonylurea, metformin, peroxisome proliferator-activated receptor gamma (PPARγ) 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DPP4i
Reference group
|
DPP4 inhibitor dispensing claim is reference
|
Canagliflozin
Exposure group
|
Canagliflozin dispensing claim is exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative hazard of composite outcome of Stroke, MI, and Mortality
Time Frame: Through study completion (a median of 120-140 days)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Womens
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Canagliflozin
Other Study ID Numbers
- 2018P002966-DUP-CANVAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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