Table 4. Summary of Changes in Safety Parameters.
| CANA | ||||||||
| PBO | CANA | 30 mg QD | CANA | CANA | CANA | CANA | ||
| PBO | (Korean) | 30 mg QD | (Korean) | 100 mg QD | 200 mg QD | 400 mg QD | 300 mg BID | |
| (n = 19) | (n = 4) | (n = 16) | (n = 15) | (n = 16) | (n = 16) | (n = 16) | (n = 13) | |
| Vital signs | ||||||||
| Supine SBP Day −1, mmHg* | 129.8±11.9 | 127.3±3.3 | 125.6±17.7 | 118.9±10.8 | 130.8±10.4 | 120.3±5.1 | 122.2±14.7 | 125.3±14.9 |
| Change Day −1 to Day 16* | –3.1±9.6 | 1.0±9.9 | –10.9±15.5 | –2.5±6.8 | –4.7±7.3 | –11.5±7.3 | –9.4±7.2 | –9.8±7.6 |
| Supine DBP Day −1, mmHg* | 79.9±8.3 | 78.1±2.6 | 74.6±7.8 | 73.9±6.1 | 78.7±7.1 | 72.7±5.3 | 71.7±6.5 | 74.4±6.8 |
| Change Day −1 to Day 16* | –0.4±6.3 | 1.2±9.7 | –3.9±6.8 | 0.1±5.2 | 0.2±6.6 | –4.5±6.1 | –3.4±5.1 | –2.9±4.5 |
| Supine pulse rate Day −1, bpm* | 70.9±7.3 | 69.3±24.1 | 71.5±13.7 | 72.3±7.3 | 73.2±7.9 | 68.0±7.4 | 71.2±6.0 | 68.1±7.0 |
| Change Day −1 to Day 16* | –3.1±9.2 | –7.3±2.2 | –7.1±10.4 | –9.2±9.3 | –9.7±5.6 | –5.1±6.1 | –4.9±6.0 | –5.5±3.9 |
| 24-hour cumulative urine electrolytes, albumin excretion, and creatinine clearance | ||||||||
| Calcium Day –1, mmol* | 4.3±2.8 | 3.5±1.1 | 3.3±1.7 | 4.2±2.3 | 4.3±2.4 | 3.8±1.9 | 4.1±1.7 | 3.3±1.9 |
| % change Day −1 to Day 16† | 8.9±14.9 | –39.8±8.2 | –2.0±8.9 | –5.5±9.1 | –7.8±6.3 | 1.9±14.1 | 2.3±6.9 | –11.7±10.5 |
| Chloride Day –1, mmol* | 202.5±56.4 | 105.2±48.7 | 227.4±79.8 | 115.7±44.5 | 238.1±59.3 | 216.3±61.4 | 204.3±48.0 | 227.6±44.6 |
| % change Day −1 to Day 16† | –11.3±6.3 | –9.9±15.6 | –17.5±5.9 | 20.3±12.8 | –7.4±5.7 | –9.6±5.2 | 35.8±10.5 | –19.5±8.2 |
| Magnesium Day –1, mmol* | 5.6±1.8 | 3.7±0.9 | 4.2±1.2 | 3.4±1.0 | 5.3±1.7 | 5.0±1.3 | 5.9±2.2 | 4.5±1.2 |
| % change Day −1 to Day 16† | –6.9±6.6 | –13.7±12.3 | 21.2±14.1 | 11.3±7.8 | 6.2±5.4 | 13.1±5.5 | 16.0±7.0 | 3.7±8.8 |
| Phosphate Day –1, mmol* | 32.6±7.7 | 16.2±6.8 | 31.0±7.9 | 13.9±4.7 | 32.8±11.5 | 31.2±7.2 | 34.3±5.8 | 30.2±7.6 |
| % change Day −1 to Day 16† | –11.7±6.3 | –17.1±14.4 | –0.5±6.4 | 21.0±9.4 | 2.5±7.0 | 7.1±6.6 | 9.6±3.7 | –3.1±6.9 |
| Potassium Day –1, mmol* | 68.7±23.5 | 43.8±18.4 | 69.0±14.9 | 40.5±11.1 | 74.0±20.2 | 68.7±14.2 | 73.9±19.7 | 68.0±19.0 |
| % change Day −1 to Day 16† | –4.5±7.2 | 14.8±23.7 | –9.0±6.0 | 31.9±9.6 | –10.1±5.3 | 12.5±8.9 | 18.7±5.2 | –3.0±8.5 |
| Sodium Day –1, mmol* | 218.2±56.4 | 111.5±33.6 | 234.0±69.5 | 118.8±45.9 | 266.2±60.6 | 225.0±51.4 | 231.3±34.7 | 233.0±50.6 |
| % change Day −1 to Day 16† | –10.6±5.7 | –12.0±5.4 | –16.5±6.2 | 14.1±9.8 | –15.0±4.9 | –0.1±6.0 | 26.3±8.2 | –22.9±6.8 |
| Albumin Day –1, mg* | 31.4±43.7 | 61.5±84.1 | 93.8±305.3 | 13.9±9.9 | 51.3±131.0 | 10.9±4.5 | 69.6±121.4 | 16.3±14.3 |
| % change Day −1 to Day 16† | –2.0±11.4 | –46.2±22.4 | 23.0±40.1 | –2.1±9.7 | 34.1±45.1 | –1.1±11.0 | –9.3±8.1 | –2.9±7.6 |
| Creatinine clearance Day –1, mL/min/1.73 m2 * | 118.6±30.8 | 59.7±24.9 | 105.1±24.7 | 51.8±14.2 | 135.4±55.8 | 106.9±23.8 | 122.4±29.1 | 104.6±24.1 |
| % change Day −1 to Day 16† | –12.9±7.9 | –35.0±6.2 | –10.7±4.7 | 47.4±13.0 | –14.7±4.7 | –7.4±5.2 | –9.3±4.7 | –14.7±9.0 |
PBO, placebo; CANA, canagliflozin; QD, once daily; BID, twice daily; SBP, systolic blood pressure; DBP, diastolic blood pressure; bpm, beats per minute; SD, standard deviation; SE, standard error.
*Data are mean ± SD.
†
Data are mean ± SE.