Table 1.
Baseline demographics and disease characteristics*
| Main study | High glycaemic substudy | ||||||
|---|---|---|---|---|---|---|---|
| Characteristic | PBO (n = 192) | CANA 100 mg (n = 195) | CANA 300 mg (n = 197) | Total (N = 584) | CANA 100 mg (n = 47) | CANA 300 mg (n = 44) | Total (N = 91) |
| Sex, n (%) | |||||||
| Male | 88 (45.8) | 81 (41.5) | 89 (45.2) | 258 (44.2) | 23 (48.9) | 19 (43.2) | 42 (46.2) |
| Female | 104 (54.2) | 114 (58.5) | 108 (54.8) | 326 (55.8) | 24 (51.1) | 25 (56.8) | 49 (53.8) |
| Age (years) | 55.7 (10.9) | 55.1 (10.8) | 55.3 (10.2) | 55.4 (10.6) | 49.7 (11.1) | 48.8 (10.8) | 49.3 (10.9) |
| Race, n (%)† | |||||||
| White | 134 (69.8) | 124 (63.6) | 137 (69.5) | 395 (67.6) | 25 (53.2) | 30 (68.2) | 55 (60.4) |
| Black or African American | 9 (4.7) | 18 (9.2) | 14 (7.1) | 41 (7.0) | 3 (6.4) | 1 (2.3) | 4 (4.4) |
| Asian | 29 (15.1) | 27 (13.8) | 29 (14.7) | 85 (14.6) | 11 (23.4) | 7 (15.9) | 18 (19.8) |
| Other‡ | 20 (10.4) | 26 (13.3) | 17 (8.6) | 63 (10.8) | 8 (17.0) | 6 (13.6) | 14 (15.4) |
| Hb A1c (%) | 8.0 (1.0) | 8.1 (1.0) | 8.0 (1.0) | 8.0 (1.0) | 10.6 (0.9) | 10.6 (0.9) | 10.6 (0.9) |
| FPG (mmol/l) | 9.3 (2.1) | 9.6 (2.4) | 9.6 (2.4) | 9.5 (2.3) | 13.3 (3.2) | 13.6 (3.2) | 13.4 (3.2) |
| Body weight (kg) | 87.6 (19.5) | 85.8 (21.4) | 86.9 (20.5) | 86.8 (20.4) | 82.8 (22.9) | 82.1 (19.0) | 82.5 (21.0) |
| BMI (kg/m2) | 31.8 (6.2) | 31.3 (6.6) | 31.7 (6.0) | 31.6 (6.2) | 30.4 (7.1) | 30.5 (5.5) | 30.5 (6.3) |
| Duration of diabetes (years) | 4.2 (4.1) | 4.5 (4.4) | 4.3 (4.7) | 4.3 (4.4) | 4.6 (4.6) | 5.2 (4.8) | 4.9 (4.7) |
| Subjects on AHA at screening, n (%) | 92 (47.9) | 94 (48.2) | 95 (48.2) | 281 (48.1) | 11 (23.4) | 10 (22.7) | 21 (23.1) |
AHA, antihyperglycaemic agent; BMI, body mass index; CANA, canagliflozin; FPG, fasting plasma glucose; HbA1c, haemoglobin A1c; PBO, placebo; s.d., standard deviation.
*
Data are mean (s.d.) unless otherwise indicated.
†
Percentages may not total 100.0% due to rounding.
‡
Including American Indian or Alaska Native, other, unknown and not reported for the main study and American Indian or Alaska Native and other for the high glycaemic substudy.