Table 1Baseline characteristics of study participants
Characteristic |
Total (n=22) |
Metformin→Dapagliflozin (n=12) |
Dapagliflozin→Metformin (n=10) |
P value |
Age, yr |
58.0 (41.0–65.8) |
58.0 (40.5–62.8) |
55.5 (47.0–70.5) |
0.539 |
Male sex |
10 (45.5) |
5 (41.7) |
5 (50.0) |
1.000 |
Weight, kg |
69.5 (63.1–75.3) |
68.2 (62.3–88.3) |
69.5 (60.7–74.6) |
0.628 |
BMI, kg/m2
|
26.3 (24.4–28.8) |
26.9 (22.7–28.9) |
25.7 (24.7–28.3) |
0.539 |
Waist circumference, cm |
86.6 (81.4–89.0) |
85.8 (79.5–89.0) |
87.4 (81.4–91.5) |
0.579 |
SBP, mm Hg |
120.5 (115.5–131.0) |
122.0 (118.3–130.3) |
119.5 (111.0–131.3) |
0.346 |
DBP, mm Hg |
78.0 (70.8–86.0) |
80.0 (72.5–84.8) |
72.5 (69.2–86.5) |
0.497 |
Fasting glucose, mg/dL |
158.0 (131.8–164.8) |
161.0 (134.0–165.3) |
154.5 (121.3–178.8) |
0.771 |
Postprandial glucose, mg/dL |
206.0 (156.0–249.0) |
206.0 (158.0–267.8) |
208.5 (156.0–225.0) |
0.771 |
HbA1c, % |
7.9 (7.2–8.5) |
7.9 (7.3–8.4) |
7.9 (7.2–8.9) |
1.000 |
Creatinine, mg/dL |
0.77 (0.61–0.95) |
0.75 (0.60–0.89) |
0.94 (0.71–1.15) |
0.017a
|
GFR, mL/min/1.73 m2
|
101.3 (70.8–124.5) |
105.8 (97.0–126.3) |
72.5 (66.7–105.2) |
0.015a
|
Dyslipidemia |
13 (61.9) |
6 (54.5) |
7 (70.0) |
0.659 |
Statin |
12 (57.1) |
6 (54.5) |
6 (60.0) |
1.000 |
Hypertension |
5 (23.8) |
2 (18.2) |
3 (30.0) |
0.450 |
ACEi/ARB |
4 (18.2) |
3 (25.0) |
1 (10.0) |
0.614 |
Calcium channel blocker |
1 (4.8) |
1 (8.3) |
0 |
1.000 |
Thiazide |
1 (4.8) |
1 (8.3) |
0 |
1.000 |
Table 2Changes 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 |
|