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 Value | Baseline | 6 Months | 12 Months | Change 6 Months from Baseline mean (std) | Change 12 Months from Baseline mean (std) |
| Hemoglobin A1C (%) | 8.4 | 7.4 | 7.3 | -0.90 (1.16) | -1.(1.12) |
| Hemoglobin A1C (mmol/mol) | 68.8 | 57.7 | 56.2 | -33.34 (12.68) | -35.(12.23) |
| Weight (kg) | 90.1 | 88.5 | 89.4 | -2.87 (4.62) | -3.24 (4.81) |
| Body Mass Index (kg/m2) | 32.1 | 31.6 | 31.8 | -1.02 (1.61) | -1.15 (1.68) |
| Waist Circumference (cm) | 107.4 | 104.7 | 105.9 | -3.11 (9.39) | -2.91 (11.12) |
| Diastolic Blood Pressure (mmHg) | 78.3 | 75.3 | 75.3 | -2.90 (8.78) | -3.50 (8.68) |
| Systolic Blood Pressure (mmHg) | 130.8 | 126.1 | 126.3 | -4.52 (13.64) | -4.65 (13.04) |
| Glomerular Filtration Rate Corrected (mL/min/1.73ml2) | 85.8 | 81.3 | 81.4 | -3.96 (10.72) | -5.55 (11.50) |
| Potassium (mmol/L) | 4.4 | 4.5 | 4.5 | 0.04 (0.37) | 0.(0.40) |
| HDLCholesterol (mmol/L) | 1.2 | 1.2 | 1.2 | 0.02 (0.43) | 0.(0.31) |
| LDLCholesterol (mmol/L) | 1.9 | 1.9 | 2.0 | 0.01 (0.57) | 0.01 (0.65) |
| Cholesterol (mmol/L) | 3.9 | 4.0 | 3.9 | 0.09 (0.76) | 0.(0.84) |
| Triglycerides (mmol/L) | 1.9 | 1.8 | 1.7 | -0.(0.96) | -0.24 (1.17) |
| Triglycerides (mg/dL) | 172.5 | 162.0 | 151.8 | -7.53 (85.28) | -21.27 (103.27) |
| Albumin/Creatinine (mg/mmol) | 4.7 | 3.5 | 4.1 | -0.28 (5.66) | -0.70 (7.96) |
| Albumin/Creatinine (mg/g) | 41.6 | 31.3 | 36.3 | -2.47 (50.11) | -6.16 (70.48) |
| Vital of Lab Value | Baseline | 6 Months | 12 Months | Change 6 Months from Baseline mean (std) | Change 12 Months from Baseline mean (std) |
| Hemoglobin A1C (%) | 8.4 | 7.4 | 7.3 | -0.90 (1.16) | -1.(1.12) |
| Hemoglobin A1C (mmol/mol) | 68.8 | 57.7 | 56.2 | -33.34 (12.68) | -35.(12.23) |
| Weight (kg) | 90.1 | 88.5 | 89.4 | -2.87 (4.62) | -3.24 (4.81) |
| Body Mass Index (kg/m2) | 32.1 | 31.6 | 31.8 | -1.02 (1.61) | -1.15 (1.68) |
| Waist Circumference (cm) | 107.4 | 104.7 | 105.9 | -3.11 (9.39) | -2.91 (11.12) |
| Diastolic Blood Pressure (mmHg) | 78.3 | 75.3 | 75.3 | -2.90 (8.78) | -3.50 (8.68) |
| Systolic Blood Pressure (mmHg) | 130.8 | 126.1 | 126.3 | -4.52 (13.64) | -4.65 (13.04) |
| Glomerular Filtration Rate Corrected (mL/min/1.73ml2) | 85.8 | 81.3 | 81.4 | -3.96 (10.72) | -5.55 (11.50) |
| Potassium (mmol/L) | 4.4 | 4.5 | 4.5 | 0.04 (0.37) | 0.(0.40) |
| HDLCholesterol (mmol/L) | 1.2 | 1.2 | 1.2 | 0.02 (0.43) | 0.(0.31) |
| LDLCholesterol (mmol/L) | 1.9 | 1.9 | 2.0 | 0.01 (0.57) | 0.01 (0.65) |
| Cholesterol (mmol/L) | 3.9 | 4.0 | 3.9 | 0.09 (0.76) | 0.(0.84) |
| Triglycerides (mmol/L) | 1.9 | 1.8 | 1.7 | -0.(0.96) | -0.24 (1.17) |
| Triglycerides (mg/dL) | 172.5 | 162.0 | 151.8 | -7.53 (85.28) | -21.27 (103.27) |
| Albumin/Creatinine (mg/mmol) | 4.7 | 3.5 | 4.1 | -0.28 (5.66) | -0.70 (7.96) |
| Albumin/Creatinine (mg/g) | 41.6 | 31.3 | 36.3 | -2.47 (50.11) | -6.16 (70.48) |
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..
