Table 2.
Changes in efficacy endpoints from baseline by study group in the intention-to-treat population (n = 100)
| Characteristicsa, b | Miglitol (n = 49) | Placebo (n = 51) | P valuec |
|---|---|---|---|
| HbA1c (%) | –0.85 ± 0.12 | –0.19 ± 0.11 | <0.001d |
| FPG (mg/dL) | –13.44 ± 5.48 | –0.20 ± 3.91 | 0.052 |
| PPG (mg/dL) | –44.8 ± 10.43 | 14.07 ± 9.47 | <0.001d |
| PSI (μU/mL) | –4.53 ± 3.91 | –3.78 ± 5.34 | 0.364 |
| AST (SGOT, U/L) | 1.96 ± 3.66 | –1.5 ± 1.23 | 0.888 |
| ALT (SGPT, U/L) | 8.40 ± 7.20 | 2.29 ± 6.66 | 0.009d |
| HDL-C | –0.50 ± 1.67 | –2.91 ± 1.39 | 0.861 |
| LDL-C | 0.81 ± 3.84 | –9.36 ± 2.90 | 0.037d |
| TG | –31.15 ± 11.16 | –2.96 ± 12.97 | 0.156 |
| Total cholesterol | 0.042 ± 4.11 | –7.0 ± 3.31 | 0.185 |
aData were presented as mean ± standard error (SE)
b HbA1c Glycated hemoglobin, FPG fasting plasma glucose, PPG postprandial plasma glucose, PSI postprandial serum insulin, AST aspartate aminotransferase, ALT alanine aminotransferase, HDL high-density lipoprotein cholesterol, LDL low-density lipoprotein cholesterol, TG triglyceride
c P values for estimation of differences between change in miglitol and placebo groups from baseline were assessed by 2-sample t test for HbA1c, FPG, and PPG and by nonparametric Wilcoxon rank-sum test for PSI, AST, ALT, HDL, LDL, and TG
d P < 0.05 indicated that the change from baseline of efficacy endpoint was significantly different between the miglitol and placebo treatment groups