Table 4 Effects of tofogliflozin on body mass index, glucose metabolism, lipid metabolism and blood pressure
Parameters | Tofogliflozin group | Conventional group | P value |
|---|---|---|---|
Body Mass Index at baseline (kg/m2) | 27.0 ± 5.8 (n = 168) | 27.0 ± 4.6 (n = 169) | 0.93 |
 Week 26 (change from baseline) | − 0.7 ± 1.0 (n = 163)§ | 0.0 ± 1.2 (n = 164) | < 0.001 |
 Week 52 (change from baseline) | − 0.8 ± 1.3 (n = 160)§ | − 0.1 ± 1.4 (n = 159) | < 0.001 |
 Week 78 (change from baseline) | − 0.8 ± 1.5 (n = 154)§ | 0.0 ± 1.5 (n = 157) | < 0.001 |
 Week 104 (change from baseline) | − 1.0 ± 1.4 (n = 154)§ | − 0.2 ± 1.8 (n = 154) | < 0.001 |
Waist circumference at baseline (cm) | 93.0 ± 12.7 (n = 149) | 93.7 ± 11.7 (n = 154) | 0.60 |
 Week 26 (change from baseline) | − 2.0 ± 6.0 (n = 128)§ | 1.0 ± 4.3 (n = 127)# | < 0.001 |
 Week 52 (change from baseline) | − 0.9 ± 6.1 (n = 127) | 1.4 ± 4.7 (n = 135)# | < 0.001 |
 Week 78 (change from baseline) | − 1.3 ± 6.5 (n = 117)* | 1.4 ± 4.3 (n = 124)§ | < 0.001 |
 Week 104 (change from baseline) | − 1.2 ± 6.0 (n = 124)* | 1.5 ± 4.3 (n = 125)§ | < 0.001 |
HbA1c at baseline (%) | 7.4 ± 0.7 (n = 169) | 7.3 ± 0.7 (n = 170) | 0.23 |
HbA1c at baseline (mmol/mol) | 57.5 ± 8.0 (n = 169) | 56.5 ± 7.8 (n = 169) | 0.23 |
 Week 26 (change from baseline) | − 0.4 ± 0.6 (n = 165)§ | 0.0 ± 0.5 (n = 165) | < 0.001 |
 Week 52 (change from baseline) | − 0.3 ± 0.7 (n = 161)§ | 0.0 ± 0.6 (n = 162) | < 0.001 |
 Week 78 (change from baseline) | − 0.3 ± 0.8 (n = 154)§ | 0.0 ± 0.7 (n = 159) | < 0.001 |
 Week 104 (change from baseline) | − 0.3 ± 0.8 (n = 156)§ | 0.1 ± 0.7 (n = 153) | < 0.001 |
Fasting blood glucose at baseline (mmol/l) | 7.8 ± 1.7 (n = 167) | 7.8 ± 1.8 (n = 168) | 0.91 |
 Week 26 (change from baseline) | − 0.9 ± 1.6 (n = 155)§ | 0.2 ± 2.1 (n = 152) | < 0.001 |
 Week 52 (change from baseline) | − 0.8 ± 1.7 (n = 150)§ | − 0.1 ± 1.8 (n = 154) | < 0.001 |
 Week 78 (change from baseline) | − 0.5 ± 1.7 (n = 145)§ | 0.1 ± 1.9 (n = 146) | 0.007 |
 Week 104 (change from baseline) | − 0.7 ± 1.9 (n = 148)§ | 0.1 ± 1.8 (n = 149) | < 0.001 |
C-peptide at baseline (ng/ml) | 1.91 ± 1.16 (n = 166) | 2.04 ± 1.24 (n = 168) | 0.34 |
 Week 52 (change from baseline) | − 0.26 ± 0.78 (n = 149)§ | − 0.20 ± 1.11 (n = 156)* | 0.61 |
 Week 104 (change from baseline) | − 0.16 ± 0.82 (n = 145)* | − 0.12 ± 1.06 (n = 149) | 0.75 |
Total cholesterol at baseline (mmol/l) | 4.96 ± 0.74 (n = 165) | 4.93 ± 0.81 (n = 163) | 0.72 |
 Week 26 (change from baseline) | 0.09 ± 0.55 (n = 156)* | − 0.03 ± 0.54 (n = 150) | 0.07 |
 Week 52 (change from baseline) | 0.07 ± 0.59 (n = 157) | − 0.04 ± 0.57 (n = 156) | 0.07 |
 Week 78 (change from baseline) | 0.09 ± 0.57 (n = 146) | − 0.05 ± 0.65 (n = 144) | 0.05 |
 Week 104 (change from baseline) | 0.10 ± 0.69 (n = 151) | − 0.05 ± 0.67 (n = 147) | 0.06 |
LDL cholesterol at baseline (mmol/l) | 2.88 ± 0.69 (n = 168) | 2.89 ± 0.66 (n = 169) | 0.87 |
 Week 26 (change from baseline) | 0.03 ± 0.52 (n = 162) | − 0.02 ± 0.51 (n = 162) | 0.47 |
 Week 52 (change from baseline) | 0.01 ± 0.50 (n = 159) | − 0.03 ± 0.51 (n = 162) | 0.49 |
 Week 78 (change from baseline) | 0.04 ± 0.50 (n = 153) | − 0.05 ± 0.59 (n = 157) | 0.14 |
 Week 104 (change from baseline) | 0.01 ± 0.62 (n = 154) | − 0.07 ± 0.57 (n = 153) | 0.25 |
HDL cholesterol at baseline (mmol/l) | 1.42 ± 0.36 (n = 169) | 1.37 ± 0.31 (n = 170) | 0.18 |
 Week 26 (change from baseline) | 0.07 ± 0.18 (n = 163)§ | 0.00 ± 0.18 (n = 162) | < 0.001 |
 Week 52 (change from baseline) | 0.06 ± 0.16 (n = 161)§ | 0.01 ± 0.18 (n = 162) | 0.009 |
 Week 78 (change from baseline) | 0.08 ± 0.22 (n = 154)§ | 0.03 ± 0.20 (n = 159) | 0.019 |
 Week 104 (change from baseline) | 0.08 ± 0.23 (n = 156)§ | 0.04 ± 0.20 (n = 154)* | 0.08 |
Triglyceride at baseline (mmol/l) | 1.20 [0.93, 1.80] (n = 167) | 1.45 [1.01, 1.88] (n = 168) | 0.06 |
 Week 26 (change from baseline) | − 0.04 [− 0.34, 0.24] (n = 152) | 0.03 [− 0.26, 0.36] (n = 150) | 0.21 |
 Week 52 (change from baseline) | − 0.03 [− 0.25, 0.23] (n = 149) | − 0.03 [− 0.37, 0.20] (n = 154)* | 0.40 |
 Week 78 (change from baseline) | − 0.01 [− 0.30, 0.23] (n = 145) | − 0.01 [− 0.34, 0.29] (n = 145) | 0.82 |
 Week 104 (change from baseline) | − 0.05 [− 0.36, 0.25] (n = 147) | − 0.03 [− 0.35, 0.30] (n = 148) | 0.95 |
Systolic blood pressure (mmHg) | 133.0 ± 14.5 (n = 165) | 134.5 ± 17.4 (n = 165) | 0.41 |
 Week 26 (change from baseline) | − 4.5 ± 13.9 (n = 160)§ | − 0.7 ± 15.3 (n = 159) | 0.021 |
 Week 52 (change from baseline) | − 6.0 ± 13.0 (n = 157)§ | − 2.7 ± 17.4 (n = 157) | 0.06 |
 Week 78 (change from baseline) | − 5.6 ± 15.4 (n = 151)§ | − 1.6 ± 18.3 (n = 152) | 0.040 |
 Week 104 (change from baseline) | − 5.3 ± 16.3 (n = 150)§ | 0.5 ± 18.0 (n = 148) | 0.004 |
Diastolic blood pressure (mmHg) | 77.7 ± 10.0 (n = 165) | 79.1 ± 10.9 (n = 165) | 0.22 |
 Week 26 (change from baseline) | − 1.7 ± 8.9 (n = 160)* | 0.1 ± 9.0 (n = 159) | 0.08 |
 Week 52 (change from baseline) | − 3.2 ± 9.3 (n = 157)§ | − 0.8 ± 10.1 (n = 157) | 0.028 |
 Week 78 (change from baseline) | − 2.7 ± 9.5 (n = 151)§ | − 1.1 ± 9.8 (n = 152) | 0.15 |
 Week 104 (change from baseline) | − 3.2 ± 10.1 (n = 150)§ | − 1.0 ± 10.0 (n = 148) | 0.05 |