Table 3 —

Change from baseline in secondary end points at week 26

Treatment group
I+PBOI+RSG 4 mg/dayI+RSG 8 mg/day
FFAs (g/I)
 Reference range: 0.05–0.25
n*101104103
 Baseline0.16 ± 0.080.17 ± 0.080.16 ± 0.07
 Week 260.18 ± 0.080.15 ± 0.800.15 ± 0.07
 Change from baseline0.01 ± 0.08−0.02 ± 0.07−0.02 ± 0.08
P0.1650.00660.0138
Triglycerides (mmol/l)
 Reference range: <2.26
n*102104103
 Baseline2.57 ± 2.272.66 ± 2.922.45 ± 2.13
 Week 263.10 ± 3.702.91 ± 2.532.50 ± 2.27
 Change from baseline0.53 ± 2.300.25 ± 3.240.05 ± 1.72
P0.02110.42530.7527
Total cholesterol (mmol/l)
 Reference range: <5.17
n*102104103
 Baseline5.36 ± 0.935.48 ± 1.065.43 ± 1.24
 Week 265.54 ± 1.295.99 ± 1.286.18 ± 1.51
 Change from baseline0.19 ± 0.850.51 ± 1.150.75 ± 1.36
P0.0262<0.0001<0.0001
HDL cholesterol (mmol/l)
 Reference range: >0.88
n*102104103
 Baseline1.20 ± 0.341.21 ± 0.381.18 ± 0.39
 Week 261.26 ± 0.351.28 ± 0.361.34 ± 0.50
 Change from baseline0.06 ± 0.20.17 ± 0.360.16 ± 0.46
P0.00060.06740.0005
LDL cholesterol (mmol/l)
 Reference range: 0–3.36
n*959898
 Baseline3.10 ± 0.843.19 ± 0.793.23 ± 0.98
 Week 263.10 ± 0.943.43 ± 0.853.73 ± 1.18
 Change from baseline (median)0.010.280.38
P0.75980.0001<0.0001
Total cholesterol:HDL ratio
n*102104103
 Baseline4.75 ± 1.4974.81 ± 1.4074.92 ± 1.595
 Week 264.63 ± 1.5465.07 ± 1.8905.08 ± 2.062
 Change from baseline (median)−0.130.110.06
P0.0630.25220.6999
LDL:HDL ratio
 Reference range: N/A
n*959898
 Baseline2.67 ± 0.9232.85 ± 0.9862.83 ± 0.956
 Week 262.53 ± 0.9592.89 ± 1.0483.00 ± 1.124
 Change from baseline (median)−0.130.050.07
P0.01060.41380.4199
  • Data are means ± SD unless otherwise indicated. FFA, free fatty acid.

  • *

    * Intent-to-treat population, last observation carried forward;

  • from paired t test;

  • parameter required nonparametric analysis.