Table 2. Changes in clinical parameters.
| Variable | Total (n=22) | Dapagliflozin treatment (n=22) | Metformin treatment (n=22) | P value |
|---|---|---|---|---|
| HbA1c, % | ||||
| Baseline | 7.4 (6.9 to 7.9) | 7.2 (6.8 to 8.0) | 7.4 (7.2 to 7.8) | 0.230 |
| Week 8 | 7.0 (6.7 to 7.3) | 7.1 (6.7 to 7.4) | 6.9 (6.7 to 7.3) | 0.595 |
| Change | −0.45 (−0.8 to −0.1) | −0.5 (−0.8 to 0) | −0.5 (−0.8 to −0.2) | 0.341 |
| P value within group | <0.001a | 0.026a | 0.001a | |
| HOMA-IR | ||||
| Baseline | 3.56 (2.81 to 5.51) | 3.51 (2.77 to 7.18) | 3.65 (2.82 to 4.60) | 0.833 |
| Week 8 | 3.42 (2.57 to 4.67) | 3.62 (2.55 to 4.59) | 3.26 (2.58 to 4.78) | 0.963 |
| Change | −0.41 (−1.91 to 0.49) | −0.52 (−2.69 to 0.20) | −0.03 (−1.14 to 0.69) | 0.231 |
| P value within group | 0.024a | 0.026a | 0.338 | |
| Total ketone body, µmol/L | ||||
| Baseline | 177.1 (121.7 to 274.5) | 163.1 (120.5 to 326.4) | 210.9 (129.0 to 248.4) | 0.707 |
| Week 8 | 185.7 (140.6 to 361.5) | 255.0 (173.6 to 581.9) | 156.7 (118.4 to 239.7) | 0.017a |
| Change | 14.8 (−96.9 to 148.4) | 93.5 (−8.1 to 255.1) | −44.9 (−92.4 to 66.1) | 0.023a |
| P value within group | 0.243 | 0.036a | 0.426 | |
| β-Hydroxybutyrate, mmol/L | ||||
| Baseline | 135.1 (88.4 to 214.2) | 119.0 (86.6 to 242.0) | 165.1 (89.5 to 203.0) | 0.742 |
| Week 8 | 141.2 (103.9 to 267.2) | 218.6 (35.8 to 114.4) | 122.7 (89.6 to 175.0) | 0.021a |
| Change | 13.9 (−66.2 to 117.4) | 74.4 (7.7 to 191.5) | −47.0 (−69.2 to 37.4) | 0.016a |
| P value within group | 0.324 | 0.036a | 0.249 | |
| Reactive hyperemic index | ||||
| Baseline | 1.57 (1.46 to 1.93) | 1.53 (1.39 to 1.76) | 1.65 (1.49 to 2.01) | 0.181 |
| Week 8 | 1.58 (1.35 to 2.10) | 1.67 (1.36 to 2.36) | 1.47 (1.35 to 2.02) | 0.534 |
| Change | 0.07 (−0.24 to 0.35) | 0.13 (−0.40 to 0.42) | −0.07 (−0.14 to 0.62) | 0.981 |
| P value within group | 0.441 | 0.475 | 0.685 | |
| Nitrotyrosine, ng/mL | ||||
| Baseline | 63.7 (37.5 to 82.2) | 67.3 (38.2 to 79.2) | 61.5 (32.7 to 95.8) | 0.981 |
| Week 8 | 67.2 (43.4 to 101.2) | 64.8 (45.8 to 103.4) | 68.9 (40.7 to 102.4) | 0.925 |
| Change | 7.4 (−7.7 to 19.2) | 9.6 (−7.2 to 20.6) | 4.3 (−9.4 to 15.1) | 0.526 |
| P value within group | 0.07 | 0.178 | 0.236 | |
| Endothelin-1, pg/mL | ||||
| Baseline | 1.37 (1.12 to 1.65) | 1.39 (1.15 to 1.57) | 1.37 (1.11 to 1.76) | 0.707 |
| Week 8 | 1.34 (1.05 to 1.55) | 1.46 (1.03 to 1.62) | 1.30 (1.05 to 1.49) | 0.307 |
| Change | −0.11 (−0.28 to 0.18) | −0.06 (−0.19 to 0.21) | −0.17 (−0.38 to 0.11) | 0.170 |
| P value within group | 0.174 | 0.897 | 0.071 | |
| Urine microalbumin/creatinine | ||||
| Baseline | 10.6 (5.6 to 31.2) | 10.2 (5.3 to 19.3) | 10.9 (5.8 to 35.3) | 0.963 |
| Week 8 | 13.3 (8.7 to 36.9) | 11.2 (9.9 to 37.2) | 13.3 (5.8 to 33.9) | 0.639 |
| Change | 1.5 (−5.6 to 11.8) | 4.1 (−6.6 to 12.2) | 1.2 (−3.8 to 11.8) | 0.725 |
| P value within group | 0.469 | 0.465 | 0.758 | |
| Urine β2-microglobulin/creatinine | ||||
| Baseline | 2.2 (1.4 to 3.2) | 2.2 (1.5 to 3.3) | 2.3 (1.5 to 3.3) | 0.699 |
| Week 8 | 2.3 (1.7 to 3.1) | 2.7 (1.8 to 3.4) | 2.2 (1.7 to 2.7) | 0.209 |
| Change | 0.0 (−1.2 to 1.0) | 0.4 (−1.0 to 1.7) | −0.3 (−1.7 to 0.6) | 0.071 |
| P value within group | 0.879 | 0.173 | 0.205 | |
| Urine NAG, ng/mL | ||||
| Baseline | 6.8 (4.2 to 10.9) | 7.4 (3.6 to 9.5) | 6.2 (4.3 to 11.5) | 0.833 |
| Week 8 | 7.2 (4.6 to 10.8) | 10.0 (6.8 to 12.1) | 5.6 (3.8 to 8.0) | 0.013a |
| Change | 0.2 (−1.8 to 1.6) | 0.9 (−1.0 to 5.4) | −0.5 (−4.9 to 0.4) | 0.018a |
| P value within group | 0.928 | 0.181 | 0.067 | |
| Body weight, kg | ||||
| Baseline | 69.7 (62.3 to 74.9) | 69.2 (61.7 to 72.6) | 70.1 (63.0 to 73.0) | 0.981 |
| Week 8 | 68.1 (62.1 to 73.0) | 68.3 (61.0 to 72.6) | 68.1 (63.4 to 73.0) | 0.805 |
| Change | −0.9 (−2.0 to 0.1) | −1.3 (−2.1 to −0.4) | −0.1 (−1.8 to 0.5) | 0.074 |
| P value within group | 0.001a | <0.001a | 0.296 | |
| GFR, mL/min/1.73 m2 | ||||
| Baseline | 100.0 (74.8 to 120.1) | 97.5 (73.1 to 120.8) | 103.2 (78.8 to 121.1) | 0.526 |
| Week 8 | 101.4 (74.2 to 118.9) | 101.1 (77.9 to 111.6) | 104.3 (73.8 to 120.4) | 0.673 |
| Change | 0.3 (−5.6 to 6.6) | 0.7 (−3.0 to 10.1) | −0.4 (−6.9 to 6.6) | 0.381 |
| P value within group | 0.649 | 0.306 | 0.709 |
Values are presented as median (interquartile range). The dapagliflozin treatment represents the initial first 8-week treatment in dapagliflozin→metformin group, and later 8-week treatment in metformin→dapagliflozin group in total 22 patients (vice versa for metformin treatment). P values show results of comparisons between groups by nonparametric test (Mann-Whitney). P values within groups are results of Wilcoxon signed rank test.
HbA1c, glycosylated hemoglobin; HOMA-IR, homeostatic model assessment of insulin resistance; NAG, N-acetyl-beta-D-glucosaminidase; GFR, glomerular filtration rate.
aFor P<0.05.