CANadian CAnagliflozin REgistry (CanCARE)—A Prospective, Observational Assessment of Canagliflozin (CANA) Treatment in Type 2 Diabetes Mellitus (T2DM)—Twelve-Month Results

Abstract

CanCARE is a Canadian multicenter, prospective cohort study that enrolled SGLT2 inhibitor-naïve adult patients with T2DM, with A1c ≥7% on a stable anti-hyperglycemic agent (AHA) regimen at baseline and eGFR ≥ 60 mL/min/1.73m2, who were initiated on CANA as part of their usual treatment. This real-world (RW)study assessed the effectiveness and safety outcomes of the enrolled cohort of 527 subjects (mean age 60.7 years, mean baseline A1c 8.3%) over 12 months. Mean A1c reduction was -1.(1.12), with an observed dose response: -0.96 for CANA 100mg, -1.20 for CANA 300mg. 84.9%, 57.9% and 33% of subjects experienced >0%, ≥3%, ≥5% weight loss, respectively. Overall, 38.8% of subjects achieved A1c <7.0%, while 41% achieved the composite endpoint of A1c reduction ≥ 0.5%, body weight loss ≥ 3%. 17.9% subjects discontinued CANA. Safety data showed 37.4% subjects had ≥ 1 Adverse Event (AE), 3.5% had serious AEs, 14.5% had AEs special Interest: genital mycotic infections (9.5%), polyuria (3.7%), UTI (1.5%), severe hypoglycemia (0.9%) and volume-related AE (0.7%). No reports to date of diabetic ketoacidosis or amputation. CANA shows sustained, clinical meaningful improvement in cardiometabolic (CM) parameters in the RW, confirming findings from Phase 3 trials. Table 1: Baseline Values, Results of CM Parameters at 6 and 12 Months After CANA Initiation.Vital of Lab ValueBaseline6 Months12 MonthsChange 6 Months from Baseline mean (std)Change 12 Months from Baseline mean (std)Hemoglobin A1C (%)8.47.47.3-0.90 (1.16)-1.(1.12)Hemoglobin A1C (mmol/mol)68.857.756.2-33.34 (12.68)-35.(12.23)Weight (kg)90.188.589.4-2.87 (4.62)-3.24 (4.81)Body Mass Index (kg/m2)32.131.631.8-1.02 (1.61)-1.15 (1.68)Waist Circumference (cm)107.4104.7105.9-3.11 (9.39)-2.91 (11.12)Diastolic Blood Pressure (mmHg)78.375.375.3-2.90 (8.78)-3.50 (8.68)Systolic Blood Pressure (mmHg)130.8126.1126.3-4.52 (13.64)-4.65 (13.04)Glomerular Filtration Rate Corrected (mL/min/1.73ml2)85.881.381.4-3.96 (10.72)-5.55 (11.50)Potassium (mmol/L)4.44.54.50.04 (0.37)0.(0.40)HDLCholesterol (mmol/L)1.21.21.20.02 (0.43)0.(0.31)LDLCholesterol (mmol/L)1.91.92.00.01 (0.57)0.01 (0.65)Cholesterol (mmol/L)3.94.03.90.09 (0.76)0.(0.84)Triglycerides (mmol/L)1.91.81.7-0.(0.96)-0.24 (1.17)Triglycerides (mg/dL)172.5162.0151.8-7.53 (85.28)-21.27 (103.27)Albumin/Creatinine (mg/mmol)4.73.54.1-0.28 (5.66)-0.70 (7.96)Albumin/Creatinine (mg/g)41.631.336.3-2.47 (50.11)-6.16 (70.48) Disclosure V.C. Woo: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. A.D. Bell: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Bayer AG, Eli Lilly and Company, Novo Nordisk Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Servier. M.A. Clement: Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis, Eli Lilly and Company. F. Camacho: Consultant; Self; Janssen Inc. N. Georgijev: Employee; Self; Janssen Scientific Affairs, LLC. J.B. Rose: Employee; Self; Janssen Pharmaceuticals, Inc. W. Rapattoni: Employee; Self; Janssen Inc, Toronto Canada. H.S. Bajaj: Speaker's Bureau; Self; Abbott. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca, Bayer AG. Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc., Mylan. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Valeant Pharmaceuticals International, Inc.. Research Support; Self; Valeant Pharmaceuticals International, Inc.. Speaker's Bureau; Self; Valeant Pharmaceuticals International, Inc..