Table 2.
Efficacy outcomes
| Outcome | Baseline | Placebo | Empagliflozin | ETD (95% CI) | P value | FDR |
|---|---|---|---|---|---|---|
| Mean glucose, mmol/L | 10.4 (2.5) | 10.2 (2.2) | 7.9 (1.5) | −2.3 (−3.3 to −1.3) | 0.0001 | — |
| CV, % | 29.6 (6.9) | 30.2 (7.3) | 32.2 (5.6) | 2.0 (−1.3 to 5.3) | 0.21 | 0.27 |
| SD, mmol/L | 3.0 (0.8) | 3.0 (0.8) | 2.6 (0.9) | −0.5 (−0.7 to −0.2) | 0.0029 | 0.0041 |
| Time in range, % | 52 (26) | 52 (22) | 78 (14) | 26 (16 to 37) | 0.0001 | 0.0003 |
| Time in tight range, % | 28 (20) | 28 (18) | 56 (14) | 28 (18 to 38) | <0.0001 | <0.0001 |
| Time above range, % | 46 (26) | 47 (24) | 19 (14) | −27 (−39 to −16) | 0.0002 | 0.0004 |
| Time below range (<3.9 mmol/L), % | 0.0 [0.0, 0.6] | 0.1 [0.0, 1.5] | 1.3 [0.2, 4.3] | 1.0 (−0.7 to 2.7) | 0.23 | 0.27 |
| Time below range (<3.0 mmol/L), % | 0.0 [0.0, 0.0] | 0.0 [0.0, 0.1] | 0.2 [0.0, 0.5] | 0.2 (−0.4 to 0.8) | 0.44 | 0.44 |
| 24-h urinary glucose excretion, g | 5 [0, 26] | 4 [1, 10] | 102 [73, 123] | 77 (48 to 106) | <0.0001 | 0.0001 |
| Missing data | 1 | 1 | 0 | |||
| Renal glucose threshold (CC-based), mmol/L | 12.3 (2.5) | 12.3 (1.6) | 4.4 (0.9) | −7.7 (−9.1 to −6.4) | <0.0001 | <0.0001 |
| Missing data | 7 | 5 | 4 | |||
| Renal glucose threshold (eGFR-based), mmol/L | 12.0 (2.4) | 12.0 (1.6) | 4.0 (1.0) | −8.2 (−9.2 to −7.2) | <0.0001 | — |
| Missing data | 7 | 5 | 3 | |||
| Urinary glucose-to-creatinine ratio, mol/mol | 1.2 [0.0, 5.4] | 0.2 [0.0, 1.1] | 29.7 [23.7, 41.4] | 32.1 (25.4 to 38.9) | <0.0001 | <0.0001 |
| Missing data | 1 | 1 | 1 | |||
| Fasting plasma ketone (BHB), mmol/L | 0.3 (0.2) | 0.4 (0.3) | 0.3 (0.2) | −0.1 (−0.2 to 0.1) | 0.31 | 0.34 |
| Fasting plasma glucose, mmol/L | 8.1 (2.2) | 8.0 (2.2) | 5.9 (0.9) | −2.1 (−3.2 to −1.1) | 0.0005 | 0.0009 |
| Body weight, kg | 77.0 (12.5) | 77.0 (12.6) | 76.3 (12.2) | −0.7 (−1.1 to −0.3) | 0.0016 | 0.0026 |
Efficacy outcomes in principal stratum population (n = 18). Data are mean (SD) or median [quartile 1, quartile 3] unless otherwise indicated. Reasons for missing data are described in Supplementary Table 2. CC, creatinine clearance (used as glomerular filtration rate in estimation of renal glucose threshold); CV, coefficient of variation (CGM metric); eGFR, estimated glomerular filtration rate (used as glomerular filtration rate in estimation); ETD, estimated treatment difference; FDR, false discovery rate.