Table 1.
Study | Efficacy Population | Safety Population | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
<75 | ≥75 | <75 | ≥75 | |||||||||
Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | Placebo | Canagliflozin 100 mg | Canagliflozin 300 mg | Non‐canagliflozin | Canagliflozin 100 mg | Canagliflozin 300 mg | Non‐canagliflozin | Canagliflozin 100 mg | Canagliflozin 300 mg | |
Monotherapy | 186 | 189 | 192 | 6 | 6 | 5 | 186 | 189 | 192 | 6 | 6 | 5 |
Add‐on to metformin | 183 | 364 | 363 | 0 | 4 | 4 | 543 | 364 | 363 | 6 | 4 | 4 |
Add‐on to metformin and sulfonylurea | 154 | 150 | 154 | 2 | 7 | 2 | 154 | 150 | 154 | 2 | 7 | 2 |
Add‐on to metformin and pioglitazone | 108 | 109 | 108 | 7 | 4 | 6 | 108 | 109 | 108 | 7 | 4 | 6 |
CANVAS add‐on to insulin substudy | 531 | 530 | 539 | 34 | 36 | 48 | — | — | — | — | — | — |
CANVAS add‐on to sulfonylurea substudy | 42 | 38 | 35 | 3 | 4 | 5 | — | — | — | — | — | — |
Add‐on to metformin vs glimepiride | — | — | — | — | — | — | 475 | 469 | 476 | 7 | 14 | 9 |
Older adults (55–80) | — | — | — | — | — | — | 225 | 221 | 222 | 12 | 20 | 14 |
Moderate renal impairment (estimated glomerular filtration rate 30 to <50 mL/min per 1.73 m2) | — | — | — | — | — | — | 68 | 66 | 70 | 22 | 24 | 19 |
CANVAS (all) | — | — | — | — | — | — | 1,348 | 1,361 | 1,328 | 93 | 84 | 113 |
Total | 1,204 | 1,380 | 1,391 | 52 | 61 | 70 | 3,107 | 2,929 | 2,913 | 155 | 163 | 172 |
CANVAS = CANagliflozin cardioVascular Assessment Study.