Table 2.
Efficacy variables
| Placebo (N = 87) |
Ipragliflozin (N = 168) |
||
|---|---|---|---|
| HbA1c, mmol/mol [%] | Baseline / EOT | 70.8 ± 9.5 / 73.7 ± 11.7 | 71.2 ± 8.4 / 62.5 ± 8.9 |
| [8.62 ± 0.86 / 8.90 ± 1.07] | [8.67 ± 0.77 / 7.88 ± 0.81] | ||
| Change | 2.9 ± 7.0 | −8.7 ± 7.2 | |
| [0.27 ± 0.65] | [−0.79 ± 0.66] | ||
| AMD (95% CI) | −11.7 (−13.5, −9.9) | ||
| [−1.07 (−1.24, −0.91)], p < .001 | |||
| FPG, mmol/L [mg/dL] | Baseline / EOT | 8.91 ± 2.41 / 9.48 ± 2.88 | 8.87 ± 2.53 / 7.26 ± 1.79 (167) |
| [160.5 ± 43.4 / 170.9 ± 52.0] | [159.9 ± 45.7 / 130.7 ± 32.3] | ||
| Change | 0.58 ± 2.19 | −1.62 ± 2.19 (167) | |
| [10.4 ± 39.6] | [−29.3 ± 39.4] | ||
| AMD (95% CI) | −2.23 (−2.70, −1.75) | ||
| [−40.3 (−48.9, −31.7)], p < .001 | |||
| Glycoalbumin, % | Baseline / EOT | 23.43 ± 3.92 / 23.63 ± 4.26 | 23.48 ± 3.58 / 19.88 ± 3.41 |
| Change | 0.20 ± 2.08 | −3.60 ± 2.33 | |
| AMD (95% CI) | −3.84 (−4.40, −3.29), p < .001 | ||
| SMBG, mmol/L [mg/dL] | |||
| Fasting | Baseline / EOT | 8.739 ± 2.353 (86) / 7.761 ± 1.831 (58) | 8.349 ± 2.355 (161) / 6.935 ± 1.492 (123) |
| [157.44 ± 42.40] / [139.82 ± 32.99] | [150.41 ± 42.44]/ [124.94 ± 26.87] | ||
| Change | −0.101 ± 1.517 (58) | −1.643 ± 1.674 (119) | |
| [−1.83 ± 27.33] | [−29.60 ± 30.16] | ||
| AMD (95% CI) | −1.185 (−1.591, −0.779), p < .001 | ||
| [−21.36 (−28.67, −14.04)], p < .001 | |||
| 1 h after breakfast | Baseline / EOT | 13.458 ± 3.131 (83) / 12.797 ± 3.229 (58) | 12.817 ± 3.029 (159) / 11.349 ± 2.374 (123) |
| [242.46 ± 56.40] / [230.53 ± 58.18] | [230.91 ± 54.57] / [204.46 ± 42.78] | ||
| Change | 0.438 ± 3.114 (57) | −1.464 ± 2.830 (117) | |
| [7.89 ± 56.08] | [−26.37 ± 50.99] | ||
| AMD (95% CI) | −1.639 (−2.431, −0.847), p < .001 | ||
| [−29.51 (−43.78, −15.24)], p < .001 | |||
| Before lunch | Baseline / EOT | 9.359 ± 3.240 (83) / 8.686 ± 2.427 (58) | 9.181 ± 2.983 (161) / 7.507 ± 2.355 (120) |
| [168.61 ± 58.38] / [156.48 ± 43.71] | [165.39 ± 53.75] / [135.24 ± 42.42] | ||
| Change | 0.247 ± 2.410 (57) | −1.852 ± 3.113 (116) | |
| [4.45 ± 43.41] | [−33.37 ± 56.07] | ||
| AMD (95% CI) | −1.464 (−2.194, −0.733), p < .001 | ||
| [−26.37 (−39.52, −13.22)], p < .001 | |||
| 1 h after lunch | Baseline / EOT | 13.340 ± 2.729 (84) / 13.271 ± 2.521 (59) | 13.201 ± 2.937 (161) / 11.866 ± 2.361 (122) |
| [240.31 ± 49.16] / [239.08 ± 45.42] | [237.81 ± 52.91] / [213.78 ± 42.53] | ||
| Change | 0.636 ± 2.523 (59) | −1.378 ± 2.955 (116) | |
| [11.45 ± 45.46] | [−24.81 ± 53.24] | ||
| AMD (95% CI) | −1.591 (−2.311, −0.871), p < .001 | ||
| [−28.65 (−41.62, −15.69)], p < .001 | |||
| Before dinner | Baseline / EOT | 9.715 ± 3.203 (84) / 9.655 ± 2.853 (59) | 9.658 ± 2.813 (161) / 7.966 ± 2.381 (121) |
| [175.02 ± 57.69] / [173.93 ± 51.41] | [173.99 ± 50.67] / [143.51 ± 42.89] | ||
| Change | 0.621 ± 2.633 (58) | −1.647 ± 2.613 (116) | |
| [11.17 ± 47.44] | [−29.67 ± 47.07] | ||
| AMD (95% CI) | −1.968 (−2.680, −1.256), p < .001 | ||
| [−35.44 (−48.26, −22.62)], p < .001 | |||
| 1 h after dinner | Baseline / EOT | 12.854 ± 3.385 (83) / 12.546 ± 3.354 (59) | 12.711 ± 3.281 (160) / 11.378 ± 2.763 (121) |
| [231.57 ± 60.99] / [226.01 ± 60.44] | [228.99 ± 59.11] / [204.98 ± 49.79] | ||
| Change | 0.602 ± 2.713 (57) | −1.404 ± 2.944 (115) | |
| [10.85 ± 48.89] | [−25.28 ± 53.04] | ||
| AMD (95% CI) | −1.489 (−2.287, −0.692), p < .001 | ||
| [−26.82 (−41.19, −12.45)], p < .001 | |||
| Before bedtime | Baseline / EOT | 12.359 ± 3.213 (84) / 11.750 ± 3.529 (59) | 11.998 ± 3.299 (156) / 10.236 ± 3.031 (120) |
| [222.65 ± 57.88] / [211.68 ± 63.56] | [216.14 ± 59.45] / [184.39 ± 54.60] | ||
| Change | 0.397 ± 3.379 (58) | −1.684 ± 2.922 (111) | |
| [7.16 ± 60.86] | [−30.34 ± 52.65] | ||
| AMD (95% CI) | −1.838 (−2.722, −0.954), p < .001 | ||
| [−33.12 (−49.05, −17.19)], p < .001 | |||
| Body weight, kg | Baseline / EOT | 70.26 ± 12.16 / 70.21 ± 11.94 | 69.03 ± 11.67 / 67.94 ± 11.58 |
| Change | −0.05 ± 1.42 | −1.09 ± 1.27 | |
| AMD (95% CI) | −1.07 (−1.41, −0.73), p < .001 | ||
| Waist circumference, cm | Baseline / EOT | 92.80 ± 9.33 / 92.00 ± 8.69 (68) | 90.79 ± 9.59 / 90.41 ± 9.37 (127) |
| Change | −0.84 ± 3.62 (68) | −1.36 ± 3.36 (127) | |
| AMD (95% CI) | −0.63 (−1.63, 0.37), p = .215 | ||
| C‐peptide, nmol/L | Baseline / EOT | 0.36 ± 0.23 / 0.37 ± 0.22 (68) | 0.33 ± 0.21 / 0.34 ± 0.21 (127) |
| Change | 0.05 ± 0.13 (68) | −0.03 ± 0.14 (127) | |
| AMD (95% CI) | −0.07 (−0.11, −0.03), p < .001 | ||
| Glucagon, ng/L | Baseline / EOT | 145.5 ± 148.5 1 / 122.4 ± 26.4 | 124.4 ± 21.9 (167) / 120.5 ± 22.3 |
| Change | −23.2 ± 150.8 | −3.9 ± 20.3 (167) | |
| AMD (95% CI) | −1.5 (−7.8, 4.8), p = .637 | ||
| Glucagon, ng/L (per‐protocol analysis set) | Baseline / EOT | 129.4 ± 25.7 / 118.6 ± 19.9 (65) | 124.6 ± 23.0 / 117.7 ± 22.2 (123) |
| Change | −10.8 ± 20.1 (65) | −6.9 ± 19.6 (123) | |
| AMD (95% CI) | 1.7 (−3.4, 6.8), p = .510 | ||
| Leptin, nmol/L | Baseline / EOT | 0.763 ± 0.511 / 0.742 ± 0.523 | 0.750 ± 0523 (167) / 0.691 ± 0.508 |
| Change | −0.021 ± 0.243 | −0.057 ± 0.219 (167) | |
| AMD (95% CI) | −0.040 (−0.097, 0.018), p = .172 | ||
| Adiponectin, µg/mL | Baseline / EOT | 7.17 ± 3.62 / 7.60 ± 3.94 | 7.24 ± 3.65 (167) / 7.99 ± 3.71 |
| Change | 0.43 ± 1.10 | 0.76 ± 1.07 (167) | |
| AMD (95% CI) | 0.33 (0.05, 0.62), p = .022 | ||
Values are presented as the mean ± standard deviation or adjusted mean difference (95% confidence interval). Where the number of patients differed from the number of patients in the full analysis set, the number is given in parentheses.
AMD, adjusted mean difference (ipragliflozin − placebo); EOT, end of the randomized treatment period; FPG, fasting plasma glucose; SMBG, self‐monitored blood glucose.
1
One patient had an outlier of 1490 ng/L, which resulted in the large standard deviation. This patient was administered glucagon prior to endoscopy on the day of the blood test at baseline. Therefore, glucagon concentrations were also analysed in the per‐protocol analysis set after excluding this outlier.