LAUSR

CANA is an SGLT2 inhibitor that was generally well tolerated in 12 placebo (PBO) and active-controlled phase 3/4 trials (non-CANVAS studies [NCS]) for ≤104 weeks in a broad range of patients with type 2 diabetes (T2D). Here we report the longest-term safety data to date (up to 6.5 years) with CANA in patients with T2D and high CV risk from the CANVAS Program vs. the NCS. Amputation and fracture were novel safety signals in the CANVAS Program (HR [95% CI]: 1.97 [1.41, 2.75] and 1.26 [1.04, 1.52]) that were not seen in the NCS (RR [95% CI]: 0.23 [0.06, 0.89] and HR [95% CI]: 1.13 [0.74, 1.72]). The incidence of labeled AEs (i.e., osmotic diuresis [OD]- and volume depletion [VD]-related AEs, hypoglycemia, urinary tract infection, genital mycotic infection [GMI], renal-related AEs, hypersensitivity, diabetic ketoacidosis) and those that were serious or led to discontinuation in the CANVAS Program and the NCS are reported. In the CANVAS Program, incidence of OD- and VD-related AEs and GMI was higher with CANA vs. PBO, consistent with NCS (Table). There were no imbalances in other labeled AEs including hypoglycemia and renal-related AEs. The rate of serious and discontinuation-related labeled AEs was similar with CANA and PBO. CANA was generally well tolerated for up to 6.5 years in the CANVAS Program with an AE profile (excluding amputation and fracture) consistent with NCS, which included a more general T2D population. Disclosure P. Hollander: Advisory Panel; Self; Novo Nordisk Inc., Eli Lilly and Company, Merck & Co., Inc.. V. Mohan: None. V.C. Woo: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. R. Oh: Employee; Self; Janssen Research & Development. G. Fulcher: Other Relationship; Self; Novo Nordisk Inc., Janssen Scientific Affairs, LLC., Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp..