Safety profile according to randomized treatment arm
| Adverse event type | Luseo 2.5 mg (n=80) | Luseo 5 mg (n=86) | Luseo 10 mg (n=79) | Placebo (n=83) | Total (n=328) |
| Adverse events | |||||
| 31 (38.75%) | 28 (32.56%) | 33 (41.77%) | 36 (43.37%) | 128 (39.02%) | |
| Adverse events of special interest | |||||
| 8 (10.00%) | 12 (13.95%) | 8 (10.13%) | 13 (15.66%) | 41 (12.50%) | |
| Urethritis | 0 (0.0%) | 1 (1.2%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) |
| Urinary tract infection | 0 (0.0%) | 1 (1.2%) | 0 (0.0%) | 2 (2.4%) | 3 (0.9%) |
| Cystitis | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.2%) | 1 (0.3%) |
| Orchitis | 0 (0.0%) | 1 (1.2%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) |
| Balanitis candida | 0 (0.0%) | 0 (0.0%) | 1 (1.3%) | 0 (0.0%) | 1 (0.3%) |
| Hypoglycemia | 8 (10.0%) | 8 (9.3%) | 5 (6.3%) | 10 (12.0%) | 31 (9.5%) |
| Polyuria | 0 (0.0%) | 0 (0.0%) | 1 (1,3%) | 0 (0.0%) | 1 (0,3%) |
| Pollakiuria | 0 (0.0%) | 1 (1.2%) | 1 (1.3%) | 0 (0.0%) | 2 (0.6%) |
| Hypotension | 0 (0.0%) | 0 (0.0%) | 2 (2.5%) | 0 (0.0%) | 2 (0.6%) |
| Blood ketone bodies increased | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.2%) | 1 (0.3%) |
| Ketonuria | 0 (0.0%) | 0 (0.0%) | 4 (5.1%) | 1 (1.2%) | 5 (1.5%) |
| Serious adverse events | |||||
| 1 (1.25%) | 1 (1.16%) | 2 (2.53%) | 2 (2.41%) | 6 (1.83%) | |
| Adverse events leading to study drug withdrawal | |||||
| 1 (1.2%) | 0 (0.0%) | 1 (1.3%) | 1 (1.2%) | 3 (0.9%) | |
luseo, luseogliflozin.