Table 2 —

Mean change from baseline in selected study variables (ITT population)

ParametersPlaceboMIGMETMIG + METMET versus MIG + MET (P)
n82808175
HbAlc (%)0.38 ± 0.120.02 ± 0.10−0.85 ± 0.12−1.39 ± 0.110.002
Fasting plasma glucose (mg/dl)−0.9 ± 5.7−1.0 ± 5.6−20.4 ± 5.1−44.8 ± 5.10.0025
Postprandial plasma glucose (mg/dl)
 60 min6.2 ± 7.8−16.3 ± 7.6−28.7 ± 7.0−81.9 ± 8.1<0.0001
 90 min6.9 ± 8.3−24.1 ± 8.5−33.7 ± 7.7−95.4 ± 9.1<0.0001
 120 min4.0 ± 8.5−23.2 ± 8.5−37.9 ± 7.9−86.4 ± 9.3<0.0001
Incremental plasma glucose AUC (mg · h/dl)7.9 ± 7.0−34.7 ± 7.2−18.0 ± 7.3−59.0 ± 7.2
Fasting plasma insulin (pmol/l)−0.3 ± 14.0−18.5 ± 14.0−17.4 ± 4.7−12.4 ± 3.8NS
Postprandial plasma insulin (pmol/l)
 60 min−48.8 ± 18.0−68.2 ± 18.1−19.9 ± 15.0−33.5 ± 14.4NS
 90 min−40.3 ± 17.4−88.4 ± 18.6−18.9 ± 14.8−81.6 ± 18.10.0143
 120 min−48.4 ± 19.0−63.6 ± 19.83.9 ± 14.8−59.1 ± 19.30.0177
Incremental plasma insulin AUC (pmol · h/l)−45.0 ± 23.1−72.8 ± 21.90.5 ± 17.7−60.1 ± 19.40.0592
Body weight (kg)−0.69 ± 0.27−0.42 ± 0.29−0.79 ± 0.33−1.87 ± 0.33NS
  • Data are mean ± SE. NS, not significant, MIG, miglitol, MET, metformin.