Table 1.
Twenty‐four‐hour glucose variables
| Variable | n | Placebo | Luseogliflozin | Difference vs placebo | p |
|---|---|---|---|---|---|
| Normally distributed variables | |||||
| 24‐h mean glucose level, mg/dl | 34 | 168.5 (156.9, 180.0) | 145.9 (134.4, 157.5) | −22.5 (−28.2, −16.8) | <0.001 |
| SD over 24 h, mg/dl | 34 | 37.1 (32.8, 41.4) | 35.3 (31.0, 39.6) | −1.8 (−5.5, 1.9) | 0.330 |
| AUC for glycaemic variability, mg/dl·h | |||||
| Throughout the day (0–24 h) | 34 | 4031.9 (3755.7, 4308.1) | 3492.6 (3216.4, 3768.8) | −539.3 (−675.9, −402.7) | <0.001 |
| After breakfast (0–5 h) | 34 | 959.8 (890.2, 1029.4) | 813.8 (744.2, 883.3) | −146.0 (−183.9, −108.1) | <0.001 |
| After lunch (5–11 h) | 34 | 1034.8 (949.5, 1120.1) | 905.8 (820.6, 991.1) | −129.0 (−176.2, −81.8) | <0.001 |
| After dinner (11–15 h) | 34 | 789.0 (729.7, 848.3) | 696.7 (637.4, 756.0) | −92.3 (−128.6, −56.0) | <0.001 |
| Sleeping period (15–24 h) | 34 | 1248.3 (1174.1, 1322.6) | 1076.3 (1002.1, 1150.6) | −172.0 (−215.6, −128.4) | <0.001 |
| Peak glucose level, mg/dl | |||||
| Throughout the day, 0–24 h | 34 | 249.4 (231.7, 267.1) | 226.3 (208.6, 243.9) | −23.1 (−35.6, −10.7) | 0.001 |
| After breakfast, 0–5 h | 34 | 244.9 (227.6, 262.1) | 218.9 (201.7, 236.2) | −25.9 (−39.1, −12.7) | <0.001 |
| After lunch, 5–11 h | 34 | 221.2 (204.3, 238.2) | 199.4 (182.5, 216.4) | −21.8 (−33.4, −10.2) | 0.001 |
| After dinner, 15–24 h | 34 | 230.2 (213.4, 247.0) | 206.7 (190.0, 223.5) | −23.5 (−35.2, −11.8) | <0.001 |
| Lowest glucose level, mg/dl | 34 | 114.8 (106.9, 122.6) | 95.0 (87.1, 102.8) | −19.8 (−26.4, −13.2) | <0.001 |
| Mean amplitude of glycaemic excursions, mg/dl | 34 | 92.6 (82.1, 103.2) | 90.7 (80.2, 101.3) | −1.9 (−12.6, 8.8) | 0.719 |
| Non‐normally distributed variables | |||||
| Proportion of time over 24 h with glucose levels in the following ranges, % | |||||
| ≥181 mg/dl | 34 | 28.1 (16.7, 53.1) | 16.3 (2.8, 32.3) | −14.8 (−20.1, −3.8) | <0.001 |
| ≥70 to ≤180 mg/dl | 34 | 71.9 (46.9, 83.3) | 83.2 (67.7, 96.5) | 14.4 (1.4, 20.1) | <0.001 |
| <70 mg/dl | 34 | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.125 |
| AUC for glucose levels ≥181 mg/dl, mg/dl·h | 34 | 149.2 (66.9, 561.7) | 80.2 (1.5, 209.0) | −77.3 (−308.5, −6.4) | <0.001 |
| AOC for glucose levels <70 mg/dl, mg/dl·h | 34 | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.125 |
| M‐value | 34 | 12.5 (6.2, 27.5) | 6.9 (3.1, 13.9) | −5.1 (−12.9, −1.8) | <0.001 |
Values are derived from 24‐h continuous glucose monitoring performed after 7 days of once‐daily administration of 2.5 mg luseogliflozin or placebo. Normally distributed variables are presented as means and 95% confidence intervals, and the differences between the two treatments were analysed using a mixed‐effects model. Non‐normally distributed variables are presented as medians (interquartile range), and differences between the two treatments were determined using the paired Wilcoxon test. Data are shown for the pharmacodynamic analysis set. Glucose: 1 mg/dl = 0.0556 mmol/l. AOC, area over the curve; AUC, area under the curve; SD, standard deviation around the mean glucose concentration.