Table 1.
Baseline demographic and disease characteristics*
| Characteristic | PBO (n = 90) | CANA 100 mg (n = 90) | CANA 300 mg (n = 89) | Total (N = 269) |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 57 (63.3) | 58 (64.4) | 48 (53.9) | 163 (60.6) |
| Female | 33 (36.7) | 32 (35.6) | 41 (46.1) | 106 (39.4) |
| Age, years | 68.2 ± 8.4 | 69.5 ± 8.2 | 67.9 ± 8.2 | 68.5 ± 8.3 |
| Race, n (%)† | ||||
| White | 78 (86.7) | 71 (78.9) | 66 (74.2) | 215 (79.9) |
| Black or African American | 0 | 3 (3.3) | 2 (2.2) | 5 (1.9) |
| Asian | 7 (7.8) | 9 (10.0) | 11 (12.4) | 27 (10.0) |
| Other‡ | 5 (5.6) | 7 (7.8) | 10 (11.2) | 22 (8.2) |
| HbA1c, % | 8.0 ± 0.9 | 7.9 ± 0.9 | 8.0 ± 0.8 | 8.0 ± 0.9 |
| FPG, mmol/l (mg/dl) | 8.9 ± 2.4 (160.4 ± 43.2) | 9.4 ± 2.6 (169.4 ± 46.3) | 8.8 ± 3.2 (158.6 ± 58.0) | 9.1 ± 2.8 (164.0 ± 49.6) |
| Body weight, kg | 92.8 ± 17.4 | 90.5 ± 18.4 | 90.2 ± 18.1 | 91.2 ± 18.0 |
| BMI, kg/m2 | 33.1 ± 6.5 | 32.4 ± 5.5 | 33.4 ± 6.5 | 33.0 ± 6.2 |
| Duration of T2DM, years | 16.4 ± 10.1 | 15.6 ± 7.4 | 17.0 ± 7.8 | 16.3 ± 8.5 |
| eGFR, ml/min/1.73 m2 | 40.1 ± 6.8 | 39.7 ± 6.9 | 38.5 ± 6.9 | 39.4 ± 6.9 |
| Median ACR, µg/mg | 31.3 | 23.7 | 30.1 | 30.0 |
| Microvascular complications, n (%) | 74 (82.2) | 73 (81.1) | 69 (77.5) | 216 (80.3) |
| Neuropathy | 45 (50.0) | 36 (40.0) | 38 (42.7) | 119 (44.2) |
| Retinopathy | 25 (27.8) | 27 (30.0) | 36 (40.4) | 88 (32.7) |
| Nephropathy | 61 (67.8) | 69 (76.7) | 65 (73.0) | 195 (72.5) |
| History of ASCVD, n (%) | 51 (56.7) | 50 (55.6) | 46 (51.7) | 147 (54.6) |
| Antihypertensive therapy at baseline, n (%) | ||||
| Agents acting on the renin-angiotensin system | 77 (85.6) | 79 (87.8) | 79 (88.8) | 235 (87.4) |
| Diuretics | 62 (68.9) | 65 (72.2) | 70 (78.7) | 197 (73.2) |
| β-blocking agents | 50 (55.6) | 51 (56.7) | 50 (56.2) | 151 (56.1) |
| Calcium channel blockers | 33 (36.7) | 40 (44.4) | 39 (43.8) | 112 (41.6) |
| Antihyperlipidemic therapy at baseline, n (%) | 70 (77.8) | 74 (82.2) | 68 (76.4) | 212 (78.8) |
PBO, placebo; CANA, canagliflozin; FPG, fasting plasma glucose; BMI, body mass index; T2DM, type 2 diabetes mellitus; eGFR, estimated glomerular filtration rate; ACR, albumin/creatinine ratio; ASCVD, atherosclerotic cardiovascular disease; SD, standard deviation.
*
Data are mean ± SD unless otherwise indicated.
†
Percentages may not total 100.0% due to rounding.
‡
Includes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, other and unknown.