Table 2.
Baseline demographic and disease characteristics *
| |
Patients <65 y |
Patients ≥65 y |
||||
|---|---|---|---|---|---|---|
|
Characteristic |
PBO |
CANA 100 mg |
CANA 300 mg |
PBO |
CANA 100 mg |
CANA 300 mg |
| (n = 509) | (n = 674) | (n = 685) | (n = 137) | (n = 159) | (n = 149) | |
| Sex, n (%) |
|
|
|
|
|
|
| Male |
263 (51.7) |
327 (48.5) |
327 (47.7) |
71 (51.8) |
81 (50.9) |
77 (51.7) |
| Female |
246 (48.3) |
347 (51.5) |
358 (52.3) |
66 (48.2) |
78 (49.1) |
72 (48.3) |
| Age, y |
53.0 ± 8.1 |
52.6 ± 8.1 |
52.8 ± 7.8 |
68.7 ± 3.5 |
70.0 ± 3.6 |
69.1 ± 3.5 |
| Race, n (%)† |
|
|
|
|
|
|
| White |
358 (70.3) |
455 (67.5) |
482 (70.4) |
112 (81.8) |
136 (85.5) |
128 (85.9) |
| Black or African American |
23 (4.5) |
40 (5.9) |
43 (6.3) |
5 (3.6) |
3 (1.9) |
5 (3.4) |
| Asian |
75 (14.7) |
99 (14.7) |
92 (13.4) |
7 (5.1) |
4 (2.5) |
8 (5.4) |
| Other‡ |
53 (10.4) |
80 (11.9) |
68 (9.9) |
13 (9.5) |
16 (10.1) |
8 (5.4) |
| HbA1c, % |
8.1 ± 1.0 |
8.0 ± 0.9 |
8.0 ± 1.0 |
7.8 ± 0.8 |
7.9 ± 0.9 |
7.9 ± 0.9 |
| FPG, mmol/L |
9.3 ± 2.2 |
9.4 ± 2.3 |
9.4 ± 2.3 |
9.0 ± 2.1 |
9.6 ± 2.4 |
9.6 ± 2.6 |
| Body weight, kg |
90.1 ± 22.3 |
91.0 ± 22.7 |
89.3 ± 22.8 |
86.3 ± 19.4 |
84.6 ± 19.7 |
84.6 ± 17.7 |
| BMI, kg/m2 |
32.2 ± 6.7 |
32.7 ± 6.6 |
32.3 ± 6.7 |
30.8 ± 5.0 |
30.8 ± 5.2 |
30.5 ± 5.2 |
| Systolic BP, mmHg |
127.4 ± 13.2 |
126.9 ± 12.6 |
127.6 ± 12.6 |
132.7 ± 13.1 |
132.5 ± 12.8 |
134.3 ± 12.5 |
| eGFR, mL/min/1.73 m2 |
90.0 ± 19.9 |
90.9 ± 19.0 |
91.3 ± 18.9 |
75.9 ± 15.1 |
77.3 ± 14.6 |
77.4 ± 13.5 |
| Duration of diabetes, y |
6.7 ± 5.4 |
6.4 ± 5.2 |
6.7 ± 5.4 |
10.2 ± 7.9 |
10.5 ± 7.0 |
10.8 ± 8.1 |
| Patients with cardiac disorders, n (%)§ |
64 (12.6) |
85 (12.6) |
87 (12.7) |
39 (28.5) |
46 (28.9) |
45 (30.2) |
| Patients on antihypertensive medications, n (%)|| | 305 (59.9) | 415 (61.6) | 408 (59.6) | 110 (80.3) | 120 (75.5) | 115 (77.2) |
PBO, placebo; CANA, canagliflozin; FPG, fasting plasma glucose; BMI, body mass index; BP, blood pressure; eGFR, estimated glomerular filtration rate; SD, standard deviation; MedDRA, Medical Dictionary for Regulatory Activities.
*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, multiple, other, unknown, and not reported.
§Defined based on the MedDRA v13.1 system organ class for cardiac disorders from medical history.
||Includes agents acting on the renin-angiotensin system, β-blocking agents, calcium channel blockers, and diuretics.