Table 2.
Changes in laboratory test values and vital signs of patients in the luseogliflozin and dipeptidyl-peptidase 4 inhibitor groups
| Patient laboratory test measures and vital signs | Week | Luseogliflozin group | DPP-4i group | Intergroup difference in adjusted mean change (95% CI) | p-Value | ||
|---|---|---|---|---|---|---|---|
| Measurement (n patients) | Adjusted mean change from baseline (SE)a | Measurement (n patients) | Adjusted mean change from baseline (SE)a | ||||
| HbA1c (%) | 0 | 7.7 ± 0.7 (277) | 7.6 ± 0.8 (272) | ||||
| 24 | 7.0 ± 0.7 (273) | − 0.7 (0.0) | 7.0 ± 0.9 (262) | − 0.7 (0.0) | 0.0 (− 0.1, 0.1) | 0.67 | |
| 52 | 7.0 ± 0.8 (265) | − 0.7 (0.0) | 7.0 ± 0.9 (262) | − 0.6 (0.0) | − 0.1 (− 0.2, 0.0) | 0.18 | |
| Weight (kg)b | 0 | 76.7 ± 15.1 (276) | 74.9 ± 15.8 (271) | ||||
| 24 | 74.1 ± 15.2 (269) | − 3.6 (0.2) | 74.6 ± 16.1 (257) | − 0.4 (0.2) | − 3.2 (− 3.8, − 2.6) | < 0.001 | |
| 52 | 73.7 ± 15.2 (264) | − 4.0 (0.3) | 74.7 ± 16.1 (257) | − 0.7 (0.3) | − 3.2 (− 3.9, − 2.5) | < 0.001 | |
| eGFR (mL/min/1.73 m2)b | 0 | 79.9 ± 17.6 (274) | 80.2 ± 19.0 (268) | ||||
| 24 | 79.2 ± 19.2 (268) | − 0.4 (0.8) | 77.8 ± 18.9 (262) | − 2.4 (0.8) | 2.0 (− 0.1, 4.0) | 0.06 | |
| 52 | 78.4 ± 18.7 (265) | − 1.6 (0.8) | 76.7 ± 17.4 (259) | − 3.3 (0.8) | 1.7 (− 0.4, 3.7) | 0.11 | |
| Systolic blood pressure (mmHg) | 0 | 134.6 ± 17.1 (274) | 133.3 ± 15.6 (270) | ||||
| 24 | 129.7 ± 16.0 (268) | − 4.2 (0.9) | 131.9 ± 16.3 (263) | − 1.4 (0.9) | − 2.8 (− 5.2, − 0.4) | 0.023 | |
| 52 | 130.0 ± 15.8 (266) | − 3.6 (0.9) | 130.2 ± 15.7 (262) | − 2.8 (0.9) | − 0.8 (− 3.2, 1.5) | 0.48 | |
| Diastolic blood pressure (mmHg) | 0 | 80.3 ± 13.0 (274) | 79.0 ± 11.6 (270) | ||||
| 24 | 77.4 ± 11.8 (268) | − 3.2 (0.6) | 78.2 ± 10.4 (263) | − 1.9 (0.6) | − 1.4 (− 3.0, 0.2) | 0.09 | |
| 52 | 77.5 ± 11.4 (266) | − 2.8 (0.6) | 76.8 ± 11.3 (262) | − 3.0 (0.6) | 0.2 (− 1.5, 1.8) | 0.85 | |
| Pulse rate (bpm) | 0 | 75.8 ± 11.5 (271) | 75.2 ± 10.6 (258) | ||||
| 24 | 75.8 ± 12.0 (261) | − 0.4 (0.6) | 76.4 ± 11.5 (254) | 0.8 (0.6) | − 1.2 (− 2.8, 0.4) | 0.13 | |
| 52 | 75.0 ± 11.9 (263) | − 1.0 (0.6) | 75.9 ± 12.1 (252) | 0.4 (0.6) | − 1.4 (− 3.1, 0.2) | 0.09 | |
| HDL-chol (mg/dL)b | 0 | 53.3 ± 13.7 (271) | 53.6 ± 14.1 (266) | ||||
| 24 | 56.5 ± 14.2 (264) | 7.3 (0.9) | 54.0 ± 14.5 (260) | 2.4 (0.9) | 4.9 (2.5, 7.4) | < 0.001 | |
| 52 | 57.0 ± 14.7 (260) | 8.5 (1.0) | 54.6 ± 15.2 (257) | 3.9 (1.0) | 4.6 (2.0, 7.3) | < 0.001 | |
| T-chol (mg/dL)b | 0 | 200.4 ± 35.1 (250) | 194.7 ± 36.0 (233) | ||||
| 24 | 200.1 ± 35.3 (246) | 0.6 (0.8) | 192.2 ± 32.9 (231) | − 1.1 (0.8) | 1.7 (− 0.5, 4.0) | 0.13 | |
| 52 | 199.6 ± 39.8 (240) | 0.7 (0.9) | 191.2 ± 32.0 (226) | − 0.7 (0.9) | 1.4 (− 1.0, 3.9) | 0.26 | |
| LDL-chol (mg/dL)b | 0 | 118.5 ± 31.0 (204) | 109.1 ± 29.8 (189) | ||||
| 24 | 117.3 ± 29.8 (213) | 2.5 (1.6) | 106.8 ± 28.4 (185) | − 1.6 (1.6) | 4.1 (− 0.2, 8.4) | 0.06 | |
| 52 | 116.5 ± 34.0 (202) | 2.1 (1.7) | 108.5 ± 29.2 (184) | 0.2 (1.8) | 1.8 (− 3.0, 6.6) | 0.46 | |
| TG (mg/dL) | 0 | 169.3 ± 112.2 (232) | 173.7 ± 133.5 (223) | ||||
| 24 | 149.3 ± 112.1 (231) | 151.0 ± 91.3 (210) | |||||
| 52 | 157.1 ± 134.5 (228) | 150.8 ± 87.2 (210) | |||||
| TG (log-transformed) (ln(mg/dL))b | 0 | 4.96 ± 0.57 (232) | 4.97 ± 0.58 (223) | ||||
| 24 | 4.84 ± 0.54 (231) | − 2.78 (0.62) | 4.86 ± 0.56 (210) | − 1.62 (0.64) | − 1.17 (− 2.84, 0.51) | 0.17 | |
| 52 | 4.86 ± 0.57 (228) | − 2.12 (0.64) | 4.87 ± 0.53 (210) | − 1.60 (0.66) | − 0.52 (− 2.26, 1.23) | 0.56 | |
| AST (IU/L) | 0 | 32.4 ± 19.6 (272) | 30.0 ± 18.6 (267) | ||||
| 24 | 27.8 ± 23.6 (268) | 31.2 ± 19.8 (261) | |||||
| 52 | 26.6 ± 19.6 (264) | 30.3 ± 18.5 (257) | |||||
| AST (log-transformed) (ln(IU/L)) | 0 | 3.35 ± 0.48 (272) | 3.28 ± 0.46 (267) | ||||
| 24 | 3.19 ± 0.43 (268) | − 0.15 (0.02) | 3.30 ± 0.49 (261) | − 0.01 (0.02) | − 0.15 (− 0.21, − 0.09) | < 0.001 | |
| 52 | 3.17 ± 0.40 (264) | − 0.16 (0.02) | 3.28 ± 0.48 (257) | − 0.03 (0.02) | − 0.14 (− 0.20, − 0.08) | < 0.001 | |
| ALT (IU/L) | 0 | 43.9 ± 32.7 (272) | 39.9 ± 27.1 (268) | ||||
| 24 | 33.5 ± 28.6 (266) | 39.5 ± 30.0 (262) | |||||
| 52 | 32.8 ± 25.8 (263) | 38.5 ± 32.0 (258) | |||||
| ALT (log-transformed) (ln(IU/L)) | 0 | 3.56 ± 0.65 (272) | 3.49 ± 0.61 (268) | ||||
| 24 | 3.31 ± 0.59 (266) | − 0.28 (0.03) | 3.45 ± 0.64 (262) | − 0.08 (0.03) | − 0.20 (− 0.27, − 0.13) | < 0.001 | |
| 52 | 3.29 ± 0.59 (263) | − 0.29 (0.03) | 3.41 ± 0.66 (258) | − 0.12 (0.03) | − 0.16 (− 0.24, − 0.09) | < 0.001 | |
| γ-GTP (IU/L) | 0 | 61.5 ± 49.8 (269) | 54.1 ± 45.0 (264) | ||||
| 24 | 53.3 ± 87.3 (266) | 60.6 ± 138.6 (260) | |||||
| 52 | 49.0 ± 57.2 (262) | 53.8 ± 61.1 (258) | |||||
| γ-GTP (log-transformed) (ln(IU/L)) | 0 | 3.86 ± 0.72 (269) | 3.75 ± 0.67 (264) | ||||
| 24 | 3.63 ± 0.71 (266) | − 0.24 (0.03) | 3.70 ± 0.75 (260) | − 0.08 (0.03) | − 0.16 (− 0.23, − 0.09) | < 0.001 | |
| 52 | 3.60 ± 0.69 (262) | − 0.26 (0.03) | 3.68 ± 0.72 (258) | − 0.12 (0.03) | − 0.14 (− 0.22, − 0.07) | < 0.001 | |
Data on measurements are presented as the mean ± SD, with the number of patients (n) given in parentheses for measurements, and data on the adjusted mean change from baseline are presented as the mean with the standard error (SE)) in parentheses
ALT alanine aminotransferase, AST aspartate aminotransferase, CI confidence interval, γ-GTP gamma-glutamyl transpeptidase, HDL-chol high-density lipoprotein cholesterol, LDL-chol low-density lipoprotein cholesterol, T-chol total cholesterol, TG triglyceride
aThe adjusted mean change of each continuous variable was estimated using models for repeated measures (MMRM) with an unstructured covariance structure with treatment group, time, interaction between treatment group and time, values at baseline, and allocation factors as fixed effects, and enrolled patients as random effects
bAdjusted mean percentage change was calculated instead of the adjusted mean change