Table 3.
Baseline and end‐of‐treatment values for bodyweight and waist circumference
| Variable | All patients | BMI <23 kg/m2 | BMI ≥23 to <25 kg/m2 | BMI ≥25 to <28 kg/m2 | BMI ≥28 kg/m2 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | Placebo | Ipragliflozin | |
| Bodyweight (kg) | ||||||||||
| n | 321 | 508 | 93 | 113 | 74 | 113 | 80 | 144 | 74 | 138 |
| Baseline | 67.7 ± 12.59 | 69.0 ± 12.87 | 57.1 ± 6.57 | 56.8 ± 6.79 | 63.4 ± 7.04 | 63.8 ± 7.13 | 70.2 ± 7.07 | 70.3 ± 7.50 | 82.7 ± 11.83 | 81.9 ± 12.60 |
| EOT | 67.2 ± 12.70 | 66.7 ± 12.69 | 56.5 ± 6.83 | 54.8 ± 7.01 | 62.7 ± 6.91 | 61.7 ± 7.04 | 69.9 ± 7.00 | 67.9 ± 7.66 | 82.2 ± 12.08 | 79.4 ± 12.35 |
| Change | −0.5 ± 1.88 | −2.2 ± 1.93 | −0.5 ± 1.44 | −2.0 ± 1.51 | −0.7 ± 1.84 | −2.1 ± 1.64 | −0.4 ± 2.11 | −2.3 ± 1.94 | −0.5 ± 2.16 | −2.5 ± 2.36 |
| Change difference (95% CI)† | −1.7 (−1.96, −1.43) | −1.4 (−1.80, −0.98) | −1.4 (−1.76, −0.74) | −2.0 (−2.57, −1.46) | −2.1 (−2.76, −1.43) | |||||
| P‐value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |||||
| Percent change (%) | −0.8 ± 2.75 | −3.3 ± 2.69 | 1.0 ± 2.53 | −3.5 ± 2.80 | −1.1 ± 2.93 | −3.2 ± 2.55 | −0.5 ± 3.01 | −3.3 ± 2.74 | −0.6 ± 2.55 | −3.1 ± 2.66 |
| Percent change difference, (95% CI)† | −2.5 (−2.88, −2.11) | −2.5 (−3.22, −1.75) | −2.0 (−2.81, −1.18) | −3.0 (−3.74, −2.16) | −2.5 (−3.28, −1.75) | |||||
| P‐value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |||||
| WC (cm) | ||||||||||
| n | 252 | 436 | 73 | 96 | 56 | 97 | 62 | 124 | 61 | 119 |
| Baseline | 89.02 ± 9.460 | 89.98 ± 9.845 | 80.32 ± 5.045 | 79.16 ± 4.710 | 85.71 ± 4.751 | 86.69 ± 4.468 | 91.19 ± 5.248 | 90.65 ± 5.889 | 100.26 ± 7.717 | 100.68 ± 8.189 |
| EOT | 88.61 ± 9.849 | 88.13 ± 9.910 | 79.16 ± 5.355 | 77.50 ± 5.056 | 85.91 ± 4.615 | 84.87 ± 4.864 | 90.63 ± 5.278 | 88.69 ± 6.071 | 100.30 ± 7.981 | 98.75 ± 8.177 |
| Change | −0.44 ± 3.438 | −1.86 ± 3.459 | −1.07 ± 2.865 | −1.69 ± 3.569 | 0.11 ± 3.196 | −1.79 ± 3.231 | −0.66 ± 3.230 | −1.99 ± 3.606 | 0.05 ± 4.310 | −1.91 ± 3.430 |
| Change difference (95% CI)† | −1.35 (−1.896, −0.807) | −0.83 (−1.837, 0.184) | −1.76 (−2.819, −0.706) | −1.40 (−2.466, −0.343) | −1.98 (−3.183, −0.770) | |||||
| P‐value | <0.001 | 0.108 | 0.001 | 0.010 | 0.001 | |||||
Values are presented as mean ± standard deviation. Baseline values were compared between the ipragliflozin and placebo groups within each body mass index (BMI) category using independent‐samples t‐tests (P > 0.05 for all baseline variables). †Adjusted mean difference between groups. CI, confidence interval; EOT, end‐of‐treatment; WC, waist circumference.