Table 2 —

Changes in glycemic parameters at week 26

Treatment group
I+PBOI+RSG 4 mg/dayI+RSG 8 mg/day
HbA1c (%)*
n103106103
 Baseline8.9 ± 1.19.1 ± 1.39.0 ± 1.3
 Week 269.0 ± 1.28.5 ± 1.47.9 ± 1.4
 Change from baseline0.1 ± 1.0−0.6 ± 1.1−1.2 ± 1.1
P0.2032<0.0001<0.0001
 Difference from PBO§−0.7−1.3
P<0.0001<0.0001
FPG (mmol/l)
n103106103
 Baseline10.8 ± 2.911.8 ± 3.211.6 ± 3.2
 Week 2611.4 ± 3.69.5 ± 3.29.1 ± 3.3
 Change from baseline0.6 ± 3.8−2.3 ± 3.9−2.5 ± 3.3
P0.1273<0.0001<0.0001
 Difference from PBO§−2.2−2.6
P<0.0001<0.0001
Insulin dose
n104106103
 Baseline (U)70.1 ± 30.471.3 ± 43.877.7 ± 36.4
 Week 26 (U)69.7 ± 31.166.5 ± 38.268.3 ± 36.7
 Change from baseline (U)−0.4 ± 5.6−4.8 ± 14.6−9.4 ± 16.7
 Percent change from baseline (%)−0.6 ± 8.2−5.6 ± 15.9−12.0 ± 20.2
  • Data are means ± SD unless otherwise indicated.

  • *

    * Reference range: <6.5;

  • intent-to-treat population, last observation carried forward;

  • paired t test;

  • §

    § adjusted mean difference, pairwise comparison;

  • from comparisons of least-squares means within generalized linear model;

  • reference range: 13–50 years, 3.9–6.4 mmol/l; ≥50 years, 3.6–6.9 mmol/l.