Table 1.
Parameter | Baseline | EMPA | Placebo | EMPA vs baseline | Placebo vs baseline | Verum vs placebo |
---|---|---|---|---|---|---|
HbA1c (%) | 6.69 ± 0.82 | 6.64 ± 0.76 | 6.89 ± 1.03 | < 0.001 | < 0.001 | < 0.001 |
HbA1c (mmol/mol) | 50 ± 9.0 | 49 ± 8.3 | 52 ± 11.3 | < 0.001 | < 0.001 | < 0.001 |
Fasting plasma glucose (mg/dl) | 136.5 ± 31.4 | 115.1 ± 19.7 | 139.2 ± 40.7 | < 0.001 | 0.384 | < 0.001 |
Body weight (kg) | 87.7 ± 12.9 | 86.6 ± 12.6 | 87.6 ± 12.9 | < 0.001 | 0.858 | < 0.001 |
Systolic OBP (mmHg) | 128 ± 13.4 | 122 ± 11.4 | 128 ± 12.7 | < 0.001 | 0.878 | < 0.001 |
Diastolic OBP (mmHg) | 77.7 ± 7.2 | 75 ± 6.7 | 78 ± 7.9 | < 0.001 | 0.999 | 0.002 |
Systolic 24-h ABP (mmHg) | 129 ± 10.4 | 127 ± 9.8 | 129 ± 9.7 | 0.053 | 0.868 | 0.021 |
Diastolic 24-h ABP (mmHg) | 79.2 ± 6.3 | 77.7 ± 6.9 | 80 ± 7.0 | 0.041 | 0.624 | 0.007 |
Central systolic BP (mmHg) | 120.3 ± 12.8 | 113.6 ± 12.1 | 118.6 ± 12.9 | < 0.001 | 0.237 | < 0.001 |
Central PP (mmHg) | 43.3 ± 11.5 | 39.1 ± 10.2 | 41.9 ± 10.7 | < 0.001 | 0.248 | 0.027 |
FWA (mmHg) | 28.9 ± 6.24 | 27.0 ± 5.64 | 28.7 ± 6.23 | 0.002 | 0.553 | 0.031 |
BWA (mmHg) | 21.2 ± 6.48 | 18.9 ± 5.98 | 20.4 ± 6.01 | < 0.001 | 0.248 | 0.045 |
Copeptin (pmol/l) | 5.65 ± 4.12 | 6.81 ± 4.13 | 5.06 ± 2.83 | 0.001 | 0.211 | < 0.001 |
Hematocrit (%) | 41.5 ± 2.78 | 43.0 ± 2.75 | 42.2 ± 2.73 | < 0.001 | 0.032 | 0.004 |
HR (bpm) | 72.5 ± 9.17 | 71.8 ± 9.18 | 72.2 ± 10.3 | 0.439 | 0.787 | 0.577 |
Cholesterol (mg/dl) | 178.1 ± 35.3 | 182.5 ± 39.0 | 180.3 ± 36.9 | 0.077 | 0.325 | 0.413 |
LDL-cholesterol (mg/dl) | 88.0 ± 24.2 | 92.9 ± 27.4 | 91.2 ± 24.3 | 0.016 | 0.061 | 0.425 |
HDL-cholesterol (mg/dl) | 52.2 ± 11.3 | 54.5 ± 12.9 | 53.4 ± 11.8 | < 0.002 | 0.086 | 0.219 |
Uric acid (mg/dl) | 6.05 ± 1.26 | 4.85 ± 1.27 | 5.89 ± 1.23 | < 0.001 | 0.061 | < 0.001 |
eGFR (ml/min/1.73 m2) | 92.7 ± 6.98 | 91.2 ± 7.42 | 92.5 ± 7.01 | < 0.001 | 0.535 | < 0.001 |
hsCRP (mg/l) | 2.10 ± 1.72 | 1.99 ± 1.19 | 1.88 ± 1.32 | 0.583 | 0.283 | 0.458 |
Data are given as mean ± SD
OBP office blood pressure, 24-h ABP 24 h ambulatory blood pressure, PP pulse pressure, FWA forward wave amplitude, BWA backward wave amplitude, HR heart rate, LDL low density lipid, HDL high density lipid, eGFR estimated glomerular filtration rate (calculated from serum creatinine using CKD-EPI formula), hsCRP high sensitive C-reactive protein