Table 2.
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 | |
HbA1c (%) | ||||||||||
n | 321 | 508 | 93 | 113 | 74 | 113 | 80 | 144 | 74 | 138 |
Baseline | 8.34 ± 0.716 | 8.32 ± 0.716 | 8.32 ± 0.679 | 8.26 ± 0.732 | 8.40 ± 0.855 | 8.35 ± 0.699 | 8.31 ± 0.677 | 8.28 ± 0.716 | 8.35 ± 0.661 | 8.39 ± 0.716 |
EOT | 8.74 ± 1.164 | 7.53 ± 0.734 | 8.72 ± 12.83 | 7.53 ± 0.694 | 8.81 ± 1.151 | 7.52 ± 0.698 | 8.66 ± 1.105 | 7.54 ± 0.805 | 8.78 ± 1.099 | 7.53 ± 0.725 |
Change | 0.40 ± 0.919 | −0.79 ± 0.664 | 0.40 ± 1.041 | −0.73 ± 0.627 | 0.41 ± 0.817 | −0.82 ± 0.649 | 0.36 ± 0.859 | −0.74 ± 0.694 | 0.43 ± 0.931 | −0.85 ± 0.674 |
Difference (95% CI) | −1.17 (−1.281, −1.067) | −1.10 (−1.331, −0.869) | −1.25 (−1.462, −1.039) | −1.12 (−1.330, −0.912) | −1.24 (−1.456, −1.020) | |||||
P‐value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | |||||
FPG (mg/dL) | ||||||||||
n | 321 | 508 | 93 | 113 | 74 | 113 | 80 | 144 | 74 | 138 |
Baseline† | 176.6 ± 34.85 | 173.1 ± 34.98 | 174.1 ± 36.08 | 171.8 ± 34.67 | 183.4 ± 37.67 | 174.1 ± 31.92 | 172.8 ± 32.23 | 174.9 ± 35.81 | 177.1 ± 32.72 | 171.4 ± 36.93 |
EOT | 182.3 ± 41.38 | 138.4 ± 24.30 | 176.5 ± 45.79 | 137.8 ± 22.26 | 192.7 ± 44.75 | 140.3 ± 26.51 | 177.5 ± 34.63 | 137.8 ± 23.92 | 184.5 ± 37.08 | 138.1 ± 24.59 |
Change | 6.1 ± 31.84 | −34.6 ± 31.27 | 2.4 ± 32.07 | −34.0 ± 31.67 | 9.4 ± 33.18 | −33.8 ± 30.37 | 4.8 ± 31.24 | −37.1 ± 29.61 | 8.8 ± 30.86 | −33.3 ± 33.45 |
Difference (95% CI)† | −41.8 (−45.56, −38.09) | −36.9 (−44.73, −29.08) | −47.4 (−55.85, −38.97) | −39.7 (−46.21, −33.14) | −44.2 (−51.80, −36.64) | |||||
P‐value | <0.001 | <0.001 | <0.001 | <0.001 | <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; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c.