Table 2.
Changes in primary endpoint and selected secondary endpoint variables (baseline to end of study visit) within Ramipril or Ramipril + Dapagliflozin treatment arms.
| Ramipril only (n = 16) | Ramipril + Dapagliflozin (n = 17) | |
|---|---|---|
| Albumin excretion rate (AER) (ug/min) | ||
| Baseline, median (IQR)* | 108.0 (72.4, 316.0) | 35.3 (27, 71.1) |
| End of study, median (IQR) | 98.8 (42.3, 184.0) | 17.9 (7.8, 119.2) |
| Difference between visits, median and IQR | −26.1 (−39, 179) | −27.5 (−114, −11) |
| p-value | 0.36 | <0.001 |
| Weight (kg) | ||
| Baseline, mean (SD) | 91.5 (13.7) | 99.0 (15.1) |
| End of study, mean (SD) | 91.2 (15.1) | 97.6 (13.9) |
| Difference between visits, mean (95% CI) | −0.24 (−1.96, 1.49) | −1.44 (−3.02, 0.14) |
| p-value | 0.78 | 0.07 |
| Body mass index (kg/m 2 ) | ||
| Baseline, mean (SD) | 30.9 (4.1) | 32.9 (3.9) |
| End of study, mean (SD) | 30.9 (4.7) | 32.6 (3.8) |
| Difference between visits, mean (95% CI) | 0.06 (−0.62, 0.75) | −0.38 (−0.92, 0.17) |
| p-value | 0.85 | 0.16 |
| Systolic blood pressure (mmHg) | ||
| Baseline, mean (SD) | 138 (21) | 139 (14) |
| End of study, mean (SD) | 137 (18) | 136 (15) |
| Difference between visits, mean (95% CI) | −1.65 (−12.52, 9.22) | −2.69 (−13.27, 7.90) |
| p-value | 0.75 | 0.60 |
| Diastolic blood pressure (mmHg) | ||
| Baseline, mean (SD) | 79 (7) | 83 (9) |
| End of study, mean (SD) | 81 (6.) | 81 (6) |
| Difference between visits, mean (95% CI) | 1.71 (−3.26, 6.67) | −2.81 (−6.88, 1.25) |
| p-value | 0.48 | 0.16 |
| Aortic pulse wave velocity (m/s) | ||
| Baseline, mean (SD) | 9.88 (2.12) | 9.06 (1.91) |
| End of study, mean (SD) | 10.00 (1.84) | 9.13 (2.03) |
| Difference between visits, mean (95% CI) | 0.12 (−0.89, 1.13) | 0.06 (−0.96, 1.08) |
| p-value | 0.81 | 0.90 |
| Central diastolic blood pressure (mmHg) | ||
| Baseline, mean (SD) | 81 (8) | 82 (9) |
| End of study, mean (SD) | 82 (6) | 80.0 (8) |
| Difference between visits, mean (95% CI) | 0.65 (−4.61, 5.91) | −2.44 (−6.09, 1.22) |
| p-value | 0.80 | 0.18 |
| Central pulse pressure (mmHg) | ||
| Baseline, mean (SD) | 47 (13) | 38 (11) |
| End of study, mean (SD) | 44 (11) | 40 (16) |
| Difference between visits, mean (95% CI) | −2.47 (−8.03, 3.09) | 2.31 (−5.11, 9.73) |
| p-value | 0.36 | 0.52 |
| Augmentation index (%) | ||
| Baseline, mean (SD) | 19.5 (8.3) | 18.9 (6.1) |
| End of study, mean (SD) | 20.7 (8.3) | 20.9 (8.9) |
| Difference between visits, mean (95% CI) | 1.20 (−2.23, 4.62) | 1.07 (−4.01, 6.15) |
| p-value | 0.47 | 0.66 |
| eGFR (ml/min/1.73 m 2 ) | ||
| Baseline, mean (SD) | 94.6 (23.5) | 98.2 (20.9) |
| End of study, mean (SD) | 93.4 (20.78) | 97.3 (24.0) |
| Difference between visits, mean (95% CI) | −1.21 (−9.26, 6.83) | −0.96 (−8.79, 6.87) |
| p-value | 0.75 | 0.80 |
| HbA1c (%) | ||
| Baseline, mean (SD) | 9.2 (1.2) | 8.9 (1.1) |
| End of study, mean (SD) | 9.8 (1.7) | 7.8 (1.3) |
| Difference between visits, mean (95% CI) | 0.72 (0.08, 1.36) | −1.03 (−1.55, −0.51) |
| p-value | 0.03 | <0.001 |
| Fasting glucose (mmol/l) | ||
| Baseline, mean (SD) | 9.7 (4.0) | 10.8 (3.3) |
| End of study, mean (SD) | 12.8 (5.3) | 9.2 (3.5) |
| Difference between visits, mean (95% CI) |
2.94 (−0.26, 6.13) | −1.34 (−2.93,0.26) |
| p-value | 0.07 | 0.09 |
| Serum sodium (mmol/l) | ||
| Baseline, mean (SD) | 138.5 (3.4) | 137.8 (2.7) |
| End of study, mean (SD) | 136.8 (3.9) | 139.8 (2.4) |
| Difference between visits, mean (95% CI) | −1.76 (−3.18, −0.35) | 2.00 (1.09, 2.91) |
| p-value | 0.02 | <0.001 |
| Serum potassium (mmol/l) | ||
| Baseline, mean (SD) | 4.4 (0.4) | 4.4 (0.5) |
| End of study, mean (SD) | 4.5 (0.4) | 4.5 (0.4) |
| Difference between visits, mean (95% CI) | 0.14 (−0.04, 0.31) | 0.13 (−0.01, 0.26) |
| p-value | 0.12 | 0.07 |
| Serum creatinine (umol/l) | ||
| Baseline, mean (SD) | 80.0 (19.5) | 74.1 (15.4) |
| End of study, mean (SD) | 79.5 (16.3) | 81.9 (29.7) |
| Difference between visits, mean (95% CI) | −0.12 (−6.90, 6.66) | 7.75 (−6.46, 21.96) |
| p-value | 0.97 | 0.26 |
| Hemoglobin (g/L) | ||
| Baseline, mean (SD) | 128.1 (13.9) | 140.9 (15.8) |
| End of study, mean (SD) | 129.2 (18.6) | 144.2 (11.9) |
| Difference between visits, mean (95% CI) |
1.18 (−2.65, 5.00) | 3.25 (−1.60, 8.10) |
| p-value | 0.52 | 0.17 |
| Haematocrit (vol%) | ||
| Baseline, mean (SD) | 38.7 (3.9) | 41.1 (5.1) |
| End of study, mean (SD) | 39.4 (5.3) | 43.2 (3.3) |
| Difference between visits, mean (95% CI) | 0.71 (−0.27, 1.70) | 2.08 (−0.06, 4.21) |
| p-value | 0.14 | 0.06 |
| Angiotensin converting enzyme 2 (ng/L) | ||
| Baseline, mean (SD) | 29.01 (45.42) | 25.83 (32.41) |
| End of study, mean (SD) | 38.38 (39.32) | 32.81 (39.71) |
| Difference between visits, mean (95% CI) | 7.90 (−14.89, 30.70) | 6.98 (−9.87, 23.83) |
| p-value | 0.47 | 0.39 |
| Aldosterone (ng/L) | ||
| Baseline, mean (SD) | 99.03 (45.36) | 84.75 (43.06) |
| End of study, mean (SD) | 116.04 (59.04) | 94.48 (41.58) |
| Difference between visits, mean (95% CI) |
16.26 (−13.12, 45.65) | 9.73 (−15.54, 35.00) |
| p-value | 0.26 | 0.42 |
| Angiotensin 1–7 (ng/l) | ||
| Baseline, mean (SD) | 54.29 (22.97) | 86.26 (31.74) |
| End of study, mean (SD) | 60.98 (17.30) | 76.08 (37.16) |
| Difference between visits, mean (95% CI) | 5.72 (−4.94, 16.38) | −10.17 (−21.34, 0.99) |
| p-value | 0.27 | 0.07 |
| Angiotensin 1-9 (ng/l) | ||
| Baseline, mean (SD) | 166.56 (36.33) | 207.55 (91.29) |
| End of study, mean (SD) | 181.95 (60.94) | 182.85 (52.15) |
| Difference between visits, mean (95% CI) | 16.16 (−20.12, 52.43) | −24.71 (−83.50, 34.09) |
| p-value | 0.36 | 0.38 |
| Active renin (ng/L) | ||
| Baseline, mean (SD) | 27.13 (38.46) | 48.10 (42.64) |
| End of study, mean (SD) | 30.91 (40.29) | 51.71 (45.78) |
| Difference between visits, mean (95% CI) | 2.54 (−23.23, 28.31) | 3.61 (−23.60, 30.82) |
| p-value | 0.84 | 0.78 |
| s-Klotho (ng/L) | ||
| Baseline, mean (SD) | 851.00 (433.02) | 795.45 (437.94) |
| End of study, mean (SD) | 739.37 (337.88) | 729.76 (321.96) |
| Percentage of difference of geometric mean (95% CI) | −34.09 (−38.22,106.41) | −65.69 (−174.2, 42.8) |
| p-value | 0.33 | 0.22 |
| FGF-23 (pg/ml) | ||
| Baseline, mean (SD) | 12.95 (11.27) | 11.67 (13.17) |
| End of study, mean (SD) | 11.78 (15.25) | 9.27 (10.71) |
| Percentage of difference of geometric mean (95% CI) | −1.31 (−3.81, 6.43) | −2.41 (−5, 0.19) |
| p-value | 0.59 | 0.07 |
Data mean (standard deviation) or median *interquartile range shown.
eGFR, estimated glomerular filtration rate; SBP, systolic blood pressure; DBP, diastolic blood pressure; FGF-23, Fibroblast growth factor 23; HDL, high density lipoprotein; LDL, low density lipoprotein; ACE, angiotensin converting enzyme.