Table 5 Laboratory variables at baseline and change from baseline to week 24 (Safety population)
Placebo | Tofogliflozin | |||||||
|---|---|---|---|---|---|---|---|---|
10 mg | 20 mg | 40 mg | ||||||
Baseline | Change | Baseline | Change | Baseline | Change | Baseline | Change | |
n | 56 | 48 | 58 | 54 | 58 | 56 | 58 | 54 |
Total serum ketones (μmol/L), Mean (SD) | 87.4 (70.89) | 29.7 (123.95) | 93.2 (85.12) | 45.6 (116.53)** | 115.1 (144.01) | 59.5 (136.24) ** | 127.9 (155.47) | 141.2 (253.68) ***†† |
Acetoacetic acid (μmol/L), Mean (SD) | 26.8 (16.66) | 7.1 (30.83) | 29.0 (21.52) | 10.7 (30.35)* | 34.5 (37.49) | 14.8 (32.49) ** | 40.1 (40.69) | 31.0 (63.09) ***†† |
β-HBA (μmol/L), Mean (SD) | 60.7 (55.07) | 22.6 (93.93) | 64.3 (65.39) | 34.7 (87.14)** | 80.6 (107.30) | 44.7 (105.67) ** | 88.0 (116.29) | 110.0 (194.65)***†† |
AST (IU/L, 37°C), Mean (SD) | 26.5 (10.48) | 0.1 (8.85) | 25.6 (11.15) | −3.2 (8.22)** | 26.1 (10.04) | −3.2 (8.23)** | 26.6 (10.63) | −3.7 (8.88)**† |
ALT (IU/L, 37°C), Mean (SD) | 28.6 (15.62) | −0.4 (10.95) | 28.7 (19.87) | −6.5 (11.56)***† | 30.10 (18.59) | −7.7 (12.37)***†† | 29.8 (17.51) | −6.8 (12.91)***†† |
γ-GTP (IU/L, 37°C), Mean (SD) | 51.3 (56.47) | −3.2 (31.69) | 44.2 (32.25) | −9.7 (22.44) ** | 52.2 (60.37) | −17.0 (33.31) ***† | 55.3 (89.75) | −17.3 (56.53)* |
BUN (mg/dL), Mean (SD) | 14.8 (3.4) | −0.2 (2.7) | 14.9 (3.3) | 1.5 (3.6) **†† | 14.6 (4.2) | 1.5 (4.1) **† | 14.2 (3.2) | 1.8 (3.5) ***†† |
SCr (mg/dL), Mean (SD) | 0.72 (0.18) | −0.02 (0.06) | 0.70 (0.15) | −0.00 (0.06) | 0.71 (0.21) | −0.02 (0.15) | 0.70 (0.16) | 0.02 (0.06)*†† |
eGFR (mL/min/1.73 m2), Mean (SD) | 83.78 (17.68) | 2.53 (9.10) | 84.68 (20.04) | 0.41 (8.48) | 86.78 (19.62) | 1.23 (12.89) | 86.00 (18.18) | −1.97 (7.97)†† |
Uric acid (mg/dL), Mean (SD) | 5.09 (1.39) | 0.10 (0.67) | 4.77 (1.01) | −0.30 (0.68) **†† | 5.01 (1.19) | −0.33 (0.78) **†† | 5.14 (1.27) | −0.14 (1.08) |