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Two large cardiovascular outcome trials of canagliflozin, comprising the CANVAS Program, will complete in early 2017: the CANagliflozin cardioVascular Assessment Study (CANVAS) and the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R). Accruing data for the sodium glucose co-transporter 2 (SGLT2) inhibitor class has identified questions and opportunities that were not apparent when the trials were designed. Accordingly, a series of modifications have been made to the planned analyses. These updates will ensure that the data from the CANVAS Program will maximize advances in scientific knowledge and patient care. The specification of the analysis strategy prior to knowledge of the trial results, their design by the independent scientific trial Steering Committee, the detailed a priori definition of the analysis plans, and the external review provided by the US Food and Drug Administration all provide maximally efficient and robust utilization of the data. The CANVAS Program should significantly advance our understanding of the effects of canagliflozin, and the broader SGLT2 inhibitor class, on a range of important efficacy and safety outcomes.

Original publication

DOI

10.1111/dom.12924

Type

Journal article

Journal

Diabetes Obes Metab

Publication Date

07/2017

Volume

19

Pages

926 - 935

Keywords

SGLT2 inhibitor, cardiovascular disease, type 2 diabetes, Aged, Biomarkers, Canagliflozin, Cardiovascular Diseases, Cohort Studies, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Cardiomyopathies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Monitoring, Equivalence Trials as Topic, Female, Follow-Up Studies, Humans, Hypoglycemic Agents, Male, Middle Aged, Mortality, Reproducibility of Results, Risk Factors, Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors