Changes in glycemic parameters at week 26
Treatment group | |||
---|---|---|---|
I+PBO | I+RSG 4 mg/day | I+RSG 8 mg/day | |
HbA1c (%)* | |||
n† | 103 | 106 | 103 |
Baseline | 8.9 ± 1.1 | 9.1 ± 1.3 | 9.0 ± 1.3 |
Week 26 | 9.0 ± 1.2 | 8.5 ± 1.4 | 7.9 ± 1.4 |
Change from baseline | 0.1 ± 1.0 | −0.6 ± 1.1 | −1.2 ± 1.1 |
P‡ | 0.2032 | <0.0001 | <0.0001 |
Difference from PBO§ | — | −0.7 | −1.3 |
P‖ | — | <0.0001 | <0.0001 |
FPG (mmol/l)¶ | |||
n† | 103 | 106 | 103 |
Baseline | 10.8 ± 2.9 | 11.8 ± 3.2 | 11.6 ± 3.2 |
Week 26 | 11.4 ± 3.6 | 9.5 ± 3.2 | 9.1 ± 3.3 |
Change from baseline | 0.6 ± 3.8 | −2.3 ± 3.9 | −2.5 ± 3.3 |
P‡ | 0.1273 | <0.0001 | <0.0001 |
Difference from PBO§ | — | −2.2 | −2.6 |
P‖ | — | <0.0001 | <0.0001 |
Insulin dose | |||
n† | 104 | 106 | 103 |
Baseline (U) | 70.1 ± 30.4 | 71.3 ± 43.8 | 77.7 ± 36.4 |
Week 26 (U) | 69.7 ± 31.1 | 66.5 ± 38.2 | 68.3 ± 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.