Remogliflozin etabonate dose | |||||||
---|---|---|---|---|---|---|---|
Placebo | 20 mg | 50 mg | 150 mg | 500 mg | 1000 mg | Total | |
Healthy Subjects | n = 10 | n = 8 | n = 8 | n = 8 | n = 8 | n = 8 | n = 10 |
n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
At least one adverse event | 4 (40) | 2 (25) | 3 (38) | 1 (13) | 3 (38) | 1 (13) | 8 (80) |
Adverse events reported by >1 subject in total | |||||||
Headache | 1 (10) | 1 (13) | 1 (13) | 0 | 2 (25) | 1 (13) | 4 (40) |
Blood creatine phosphokinase increased | 1 (10) | 0 | 0 | 0 | 1 (13) | 0 | 2 (20) |
Drug-related adverse events | |||||||
Headache | 1 (10) | 1 (13) | 1 (13) | 0 | 0 | 1 (13) | 3 (30) |
Dizziness | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (10) |
Diarrhea | 0 | 1 (13) | 0 | 0 | 0 | 0 | 1 (10) |
Hot flush | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (10) |
T2DM subjects | n = 6 | n = 6 | n = 6 | n = 6 | |||
n (%) | n (%) | n (%) | n (%) | ||||
At least one adverse event | 3 (50) | 1 (17) | 2 (33) | 4 (67) | |||
Adverse events reported by >1 subject in total | |||||||
Muscle cramp | 1 (17) | 1 (17) | 0 | 2 (33) | |||
β2-microglobulin increased | 0 | 0 | 2 (33) | 2 (33) | |||
Drug-related adverse events | |||||||
Nausea | 0 | 0 | 1 (17) | 1 (17) | |||
β2-microglobulin increased | 0 | 0 | 1 (17) | 1 (17) | |||
Pain in extremity | 0 | 0 | 1 (17) | 1 (17) |