Table 2 Changes from baseline to week 24 in clinical parameters, grouped according to baseline metformin use
Variables | Metformin | No metformin | ||||
|---|---|---|---|---|---|---|
Empagliflozin (n = 25) | Placebo (n = 28) | P value* | Empagliflozin (n = 27) | Placebo (n = 25) | P value* | |
Systolic blood pressure (mmHg) | ||||||
 Baseline | 136.0 ± 15.9 | 134.5 ± 15.9 | 0.733 | 129.9 ± 14.1 | 131.4 ± 12.9 | 0.690 |
 Week 24 | 123.8 ± 14.4 | 132.1 ± 12.5 | 0.031 | 126.0 ± 14.6 | 128.8 ± 14.6 | 0.503 |
 Change from baseline to week 24 | − 12.0 ± 14.9 | − 2.4 ± 10.9 | 0.012 | − 3.5 ± 17.1 | − 1.9 ± 13.7 | 0.718 |
Diastolic blood pressure (mmHg) | ||||||
 Baseline | 77.3 ± 12.3 | 75.5 ± 8.6 | 0.557 | 75.6 ± 11.0 | 74.3 ± 10.6 | 0.671 |
 Week 24 | 72.0 ± 10.8 | 74.6 ± 11.7 | 0.420 | 73.2 ± 7.6 | 74.9 ± 11.0 | 0.536 |
 Change from baseline to week 24 | − 5.0 ± 8.2 | − 1.0 ± 9.5 | 0.110 | − 2.5 ± 9.1 | 0.8 ± 10.5 | 0.243 |
Heart rate (bpm) | ||||||
 Baseline | 75.3 ± 12.7 | 71.2 ± 10.1 | 0.202 | 72.5 ± 14.0 | 72.7 ± 9.7 | 0.952 |
 Week 24 | 72.4 ± 11.6 | 70.4 ± 9.7 | 0.495 | 75.8 ± 19.5 | 71.6 ± 11.0 | 0.351 |
 Change from baseline to week 24 | − 2.3 ± 9.8 | − 0.8 ± 7.2 | 0.547 | 3.1 ± 19.1 | − 0.4 ± 9.8 | 0.410 |
Double product | ||||||
 Baseline | 10,166.64 ± 1683.93 | 9607.00 ± 1922.19 | 0.264 | 9499.78 ± 2440.30 | 9594.64 ± 1813.02 | 0.874 |
 Week 24 | 8916.54 ± 1517.31 | 9344.29 ± 1781.22 | 0.354 | 9502.46 ± 2314.20 | 9214.26 ± 1811.87 | 0.628 |
 Change from baseline to week 24 | − 1147.13 ± 1693.95 | − 262.71 ± 1082.76 | 0.034 | 3.46 ± 2711.37 | − 223.91 ± 1400.61 | 0.710 |
Body mass index (kg/m2) | ||||||
 Baseline | 26.24 ± 6.11 | 27.41 ± 6.35 | 0.496 | 26.29 ± 4.04 | 26.11 ± 4.43 | 0.876 |
 Week 24 | 25.40 ± 5.75 | 27.36 ± 6.03 | 0.236 | 25.94 ± 4.14 | 25.95 ± 4.69 | 0.995 |
 Change from baseline to week 24 | − 1.02 ± 0.83 | − 0.05 ± 0.98 |  < .001 | − 0.48 ± 1.03 | − 0.17 ± 0.86 | 0.246 |
Fasting plasma glucose (mg/dL) | ||||||
 Baseline | 141.17 ± 21.40 | 150.46 ± 28.67 | 0.188 | 141.69 ± 28.26 | 141.75 ± 40.94 | 0.995 |
 Week 24 | 121.17 ± 22.74 | 145.50 ± 41.50 | 0.011 | 134.70 ± 26.38 | 145.57 ± 44.97 | 0.324 |
 Change from baseline to week 24 | − 22.30 ± 19.86 | − 4.96 ± 40.70 | 0.054 | − 13.57 ± 23.50 | 4.26 ± 33.69 | 0.044 |
Glycohemoglobin (%) | ||||||
 Baseline | 7.30 ± 0.72 | 7.33 ± 0.65 | 0.864 | 7.02 ± 0.89 | 7.05 ± 1.08 | 0.916 |
 Week 24 | 6.95 ± 0.61 | 7.52 ± 0.81 | 0.006 | 6.87 ± 0.67 | 6.95 ± 0.83 | 0.704 |
 Change from baseline to week 24 | − 0.35 ± 0.42 | 0.19 ± 0.62 |  < .001 | − 0.15 ± 0.54 | − 0.08 ± 0.79 | 0.703 |
Glycoalbumin (%) | ||||||
 Baseline | 18.50 ± 2.68 | 18.50 ± 2.83 | 0.996 | 17.78 ± 3.41 | 18.45 ± 3.97 | 0.541 |
 Week 24 | 17.00 ± 2.40 | 18.73 ± 3.07 | 0.027 | 16.58 ± 3.26 | 17.97 ± 3.81 | 0.188 |
 Change from baseline to week 24 | − 1.51 ± 1.60 | 0.23 ± 1.68 |  < .001 | − 1.23 ± 1.99 | 0.03 ± 2.67 | 0.087 |
NT-proBNP (pg/mL) | ||||||
 Baseline | 54.64 (32.35 to 92.28) | 42.75 (27.33 to 66.88) | 0.467 | 92.07 (52.02 to 162.96) | 158.56 (79.24 to 317.25) | 0.217 |
 Week 24 | 51.23 (31.79 to 82.55) | 37.24 (23.54 to 58.92) | 0.326 | 85.19 (49.55 to 146.46) | 138.01 (75.76 to 251.39) | 0.223 |
 Proportional change from baseline to week 24 | 0.97 (0.76 to 1.23) | 0.87 (0.67 to 1.14) | 0.551 | 1.03 (0.77 to 1.36) | 0.92 (0.69 to 1.22) | 0.579 |
hs-TnI (pg/mL) | ||||||
 Baseline | 3.64 (2.73 to 4.86) | 3.20 (2.45 to 4.18) | 0.501 | 5.02 (2.89 to 8.72) | 8.78 (4.68 to 16.44) | 0.174 |
 Week 24 | 3.22 (2.33 to 4.45) | 3.06 (2.26 to 4.14) | 0.813 | 6.36 (3.30 to 12.26) | 9.54 (5.07 to 17.95) | 0.362 |
 Proportional change from baseline to week 24 | 0.85 (0.71 to 1.03) | 0.92 (0.82 to 1.04) | 0.490 | 1.16 (1.02 to 1.32) | 1.20 (0.94 to 1.54) | 0.788 |