Table 3.
Baseline demographic and clinical characteristics and PRO scores in the pooled population
| Placebo/sitagliptin (n = 1102) | Canagliflozin (n = 1434) | |
|---|---|---|
| Baseline characteristics | ||
| Age, years | ||
| Mean (SD) | 56.2 (9.3) | 56.0 (9.4) |
| Sex, n (%) | ||
| Female | 528 (47.9) | 717 (50.0) |
| Male | 574 (52.1) | 717 (50.0) |
| Race, n (%) | ||
| White | 778 (70.6) | 1017 (70.9) |
| Asian | 132 (12.0) | 188 (13.1) |
| African American or Black | 82 (7.4) | 88 (6.1) |
| American Indian or Alaska Native | 13 (1.2) | 14 (1.0) |
| Native Hawaiian or Other Pacific Islander | 4 (0.4) | 3 (0.2) |
| Other | 71 (6.4) | 105 (7.3) |
| Multiple | 18 (1.6) | 15 (1.0) |
| Unknown | 0 (0.0) | 1 (0.1) |
| Not reported | 4 (0.4) | 3 (0.2) |
| BMI, kg/m2 | ||
| Mean (SD) | 31.8 (6.3) | 32.1 (6.5) |
| HbA1c, % | ||
| Mean (SD) | 8.0 (0.9) | 8.1 (0.9) |
| Systolic blood pressure, mmHg | ||
| Mean (SD) | 129 (13.4) | 130 (13.0) |
| Diastolic blood pressure, mmHg | ||
| Mean (SD) | 78.2 (8.2) | 78.4 (8.2) |
| Study, n (%) | ||
| Study 1 | 502 (45.6) | 691 (48.2) |
| Study 2 | 141 (12.8) | 291 (20.3) |
| Study 3 | 355 (32.2) | 349 (24.3) |
| Study 4 | 104 (9.4) | 103 (7.2) |
| Treatment, n (%) | ||
| Canagliflozin | 0 (0.0) | 1434 (100.0) |
| Placebo | 408 (37.0) | 0 (0.0) |
| Sitagliptin | 694 (63.0) | 0 (0.0) |
| Baseline PRO scores | ||
| CHES-Q satisfaction with weight | ||
| n | 1102 | 1434 |
| Dissatisfied, n (%) | 795 (72.1) | 1029 (71.8) |
| Satisfied, n (%) | 307 (27.9) | 405 (28.2) |
| CHES-Q physical domain | ||
| n | 938 | 1292 |
| Median (IQR) | 4.33 (3.33–5.33) | 4.17 (3.17–5.33) |
| Range | 1–7 | 1–7 |
| CHES-Q emotional domain | ||
| n | 938 | 1292 |
| Median (IQR) | 5.67 (4.33–6.00) | 5.33 (4.33–6.00) |
| Range | 1–7 | 1–7 |
| IWQoL-Lite total score | ||
| n | 849 | 1195 |
| Median (IQR) | 85.5 (68.5–94.4) | 84.7 (68.5–94.4) |
| Range | 0–100 | 0–100 |
| SF-36 MCS | ||
| n | 848 | 1191 |
| Median (IQR) | 50.9 (43.0–57.1) | 49.6 (41.6–56.2) |
| Range | 0–100 | 0–100 |
| SF-36 PCS | ||
| n | 848 | 1191 |
| Median (IQR) | 48.3 (42.2–53.2) | 48.8 (42.3–53.6) |
| Range | 0–100 | 0–100 |
BMI body mass index, CHES-Q Current Health Satisfaction Questionnaire, HbA1c glycosylated hemoglobin, IQR interquartile range, IWQoL-Lite Impact of Weight on Quality of Life-Lite, MCS mental component summary score, PCS physical component summary score, PRO patient-reported outcome, SD standard deviation, SF-36 Short Form-36