Glycemic control
During the main UTOPIA study, HbA1c and fasting blood glucose levels significantly decreased in the tofogliflozin group but not in the conventional treatment group, resulting in a significant intergroup difference in changes. Significant improvements in HbA1c and fasting blood levels were maintained throughout the follow-up period in the tofogliflozin group (Table Effects of tofogliflozin on clinical laboratory tests26.7 ± 5.4(n = 146)26.7 ± 4.4(n = 144)25.8 ± 5.5(n = 145)− 0.9 ± 1.4(p < 0.001)26.6 ± 4.2(n = 144)− 0.2 ± 1.8(p = 0.21)− 0.7 (− 1.1, − 0.4)(p < 0.001)25.5 ± 4.9(n = 143)− 1.2 ± 2.3(p < 0.001)26.1 ± 4.0(n = 137)− 0.6 ± 2.1(p = 0.001)− 0.6 (− 1.2, − 0.1)(p = 0.021)92.5 ± 12.1(n = 131)93.1 ± 11.2(n = 130)91.8 ± 13.3(n = 126)− 1.2 ± 6.1(p = 0.039)94.3 ± 10.8(n = 129)1.4 ± 4.3(p < 0.001)− 2.6 (− 3.9, − 1.2)(p < 0.001)90.5 ± 11.9(n = 108)− 1.5 ± 6.0(p = 0.011)93.4 ± 9.6(n = 111)0.4 ± 5.1(p = 0.48)− 1.9 (− 3.4, − 0.3)(p = 0.016)7.4 ± 0.7(n = 146)7.3 ± 0.7(n = 145)7.1 ± 0.7(n = 146)− 0.3 ± 0.8(p < 0.001)7.3 ± 0.9(n = 144)0.1 ± 0.7(p = 0.24)− 0.4 (− 0.6, − 0.2)(p < 0.001)7.2 ± 0.8(n = 145)− 0.2 ± 0.8(p = 0.001)7.3 ± 0.8(n = 140)0.0 ± 0.8(p = 0.97)− 0.2 (− 0.4, 0.0)(p = 0.019)57.6 ± 7.9(n = 146)56.0 ± 7.7(n = 145)53.8 ± 8.0(n = 146)− 3.8 ± 8.2(p < 0.001)56.8 ± 10.2(n = 144)0.7 ± 7.4(p = 0.24)− 4.5 (− 6.3, − 2.7)(p < 0.001)55.1 ± 8.5(n = 145)− 2.5 ± 9.1(p = 0.001)55.9 ± 8.9(n = 140)0.0 ± 8.5(p = 0.97)− 2.5 (− 4.5, − 0.4)(p = 0.019)7.9 ± 1.8(n = 146)7.8 ± 1.9(n = 145)7.2 ± 1.5(n = 140)− 0.7 ± 1.8(p < 0.001)8.0 ± 2.0(n = 141)0.1 ± 1.8(p = 0.41)− 0.8 (− 1.3, − 0.4)(p < 0.001)7.5 ± 1.8(n = 131)− 0.4 ± 2.2(p = 0.033)7.9 ± 2.3(n = 126)0.0 ± 2.5(p = 0.92)− 0.4 (− 1.0, 0.2)(p = 0.18)0.73 ± 0.20(n = 145)0.73 ± 0.20(n = 144)0.75 ± 0.22(n = 146)0.02 ± 0.11(p = 0.012)0.76 ± 0.23(n = 145)0.03 ± 0.10(p = 0.001)− 0.01 (− 0.03, 0.02)(p = 0.61)0.77 ± 0.22(n = 143)0.05 ± 0.12(p < 0.001)0.82 ± 0.43(n = 137)0.10 ± 0.32(p < 0.001)− 0.05 (− 0.11, 0.00)(p = 0.07)UAE(ln(mg/g・Cr))2.86 ± 1.41(n = 138)3.10 ± 1.61(n = 134)2.76 ± 1.48(n = 145)− 0.09 ± 1.00(p = 0.31)3.20 ± 1.67(n = 140)0.14 ± 0.85(p = 0.07)− 0.22 (− 0.44, 0.00)(p = 0.05)3.00 ± 1.34(n = 131)0.16 ± 0.99(p = 0.07)3.31 ± 1.71(n = 130)0.19 ± 1.16(p = 0.07)− 0.02 (− 0.29, 0.24)(p = 0.86)80.6 ± 20.7(n = 145)81.6 ± 24.6(n = 144)77.6 ± 19.4(n = 146)− 2.9 ± 11.9(p = 0.004)78.2 ± 23.2(n = 145)− 3.4 ± 10.3(p < 0.001)0.4 (− 2.1, 3.0)(p = 0.74)74.4 ± 18.2(n = 143)− 6.4 ± 12.7(p < 0.001)73.9 ± 22.7(n = 137)− 8.4 ± 13.3(p < 0.001)1.9 (− 1.2, 5.0)(p = 0.22)4.97 ± 0.74(n = 144)4.92 ± 0.78(n = 140)5.04 ± 0.87(n = 145)0.07 ± 0.68(p = 0.20)4.86 ± 0.85(n = 139)− 0.05 ± 0.66(p = 0.33)0.13 (− 0.03, 0.28)(p = 0.11)4.96 ± 0.94(n = 141)0.01 ± 0.79(p = 0.87)4.74 ± 0.91(n = 136)− 0.17 ± 0.81(p = 0.020)0.18 (− 0.01, 0.37)(p = 0.07)2.90 ± 0.69(n = 145)2.87 ± 0.62(n = 145)2.91 ± 0.77(n = 144)0.00 ± 0.63(p = 0.96)2.81 ± 0.70(n = 144)− 0.07 ± 0.55(p = 0.14)0.07 (− 0.07, 0.20)(p = 0.35)2.79 ± 0.76(n = 140)− 0.11 ± 0.75(p = 0.07)2.70 ± 0.76(n = 136)− 0.16 ± 0.73(p = 0.014)0.04 (− 0.13, 0.22)(p = 0.64)1.43 ± 0.36(n = 146)1.38 ± 0.31(n = 145)1.50 ± 0.36(n = 146)0.07 ± 0.20(p < 0.001)1.42 ± 0.34(n = 145)0.04 ± 0.20(p = 0.016)0.03 (− 0.02, 0.08)(p = 0.20)1.52 ± 0.39(n = 144)0.09 ± 0.21(p < 0.001)1.41 ± 0.34(n = 140)0.04 ± 0.23(p = 0.037)0.05 (0.00, 0.11)(p = 0.039)0.24 ± 0.51(n = 146)0.34 ± 0.44(n = 145)0.21 ± 0.51(n = 139)− 0.03 ± 0.38(p = 0.42)0.28 ± 0.48(n = 140)− 0.04 ± 0.41(p = 0.20)0.02 (− 0.07, 0.11)(p = 0.69)0.19 ± 0.50(n = 129)− 0.02 ± 0.41(p = 0.52)0.27 ± 0.51(n = 126)− 0.06 ± 0.40(p = 0.08)0.04 (− 0.06, 0.14)(p = 0.44)133.5 ± 14.6(n = 142)134.1 ± 15.7(n = 140)128.5 ± 14.5(n = 145)− 4.9 ± 15.8(p < 0.001)134.3 ± 17.5(n = 144)0.4 ± 17.3(p = 0.80)− 5.3 (− 9.2, − 1.4)(p = 0.008)127.9 ± 15.4(n = 143)− 6.0 ± 15.7(p < 0.001)132.7 ± 16.9(n = 137)− 1.1 ± 19.6(p = 0.52)− 4.9 (− 9.1, − 0.7)(p = 0.023)78.1 ± 10.3(n = 142)79.1 ± 10.5(n = 140)74.9 ± 10.4(n = 145)− 3.3 ± 9.9(p < 0.001)77.8 ± 9.9(n = 144)− 1.3 ± 9.6(p = 0.13)− 2.0 (− 4.3, 0.3)(p = 0.08)74.8 ± 11.7(n = 143)− 3.2 ± 12.2(p = 0.002)77.4 ± 10.7(n = 137)− 1.9 ± 12.2(p = 0.08)− 1.4 (− 4.3, 1.5)(p = 0.35)Data are presented as the mean ± standard deviation. Intragroup differences from the baseline were analyzed using a one-sample t-test. Intergroup differences in changes from baseline (treatment effect) were analyzed using Student’s t-testHbA1c: hemoglobin A1c; UAE: urinary albumin excretion; eGFR: estimated glomerular filtration rate; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; 95% CI: 95% confidence interval