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Table 5 Laboratory variables at baseline and change from baseline to week 24 (Safety population)

From: Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

  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)
  1. *P < 0.05, **P < 0.01, and ***P < 0.001 vs. baseline.
  2. P < 0.05, ††P < 0.01, and †††P < 0.001 vs. placebo.
  3. Abbreviations: β-HBA β-hydroxybutyrate, AST aspartate aminotransferase, ALT alanine aminotransferase, GTP glutamyl transpeptidase, BUN blood urea nitrogen, SCr serum creatinine, eGFR estimated glomerular filtration rate.