Variable | HRI | RAI | P value |
n=69 | n=67 | ||
Total daily insulin dose, U/day* | |||
Baseline | 61.1 (57.7 to 64.6) | 60.9 (57.4 to 64.4) | |
Week 12 | 61.9 (58.4 to 65.4) | 62.7 (59.2 to 66.3) | |
Change from baseline | 0.77 (−0.71 to 2.24) | 1.84 (0.3 to 3.39) | |
ETD | −1.08 (−3.21 to 1.06) | 0.32 | |
Total daily insulin dose, U/kg* | |||
Baseline | 0.65 (0.61 to 0.69) | 0.65 (0.61 to 0.69) | |
Week 12 | 0.66 (0.62 to 0.70) | 0.67 (0.62 to 0.71) | |
Change from baseline | 0.008 (−0.01 to 0.026) | 0.019 (−0.0002 to 0.037) | |
ETD | −0.011 (−0.037 to 0.015) | 0.42 | |
Body weight, kg (SD) | |||
Baseline | 95.7 (91.5 to 100.0) | 96.1 (91.8 to 100.4) | |
Week 12 | 95.8 (91.5 to 100.0) | 96.6 (92.3 to 100.9) | |
Change from baseline | 0.04 (−0.68 to 0.75) | 0.48 (−0.26 to 1.23) | |
ETD | −0.45 (−1.48 to 0.58) | 0.39 |
*Results are presented as least squares means (95% CIs) from mixed-effects linear models.
ETD, estimated treatment difference between HRI versus RAI; HRI, human regular insulin; ITT, intent-to-treat; RAI, rapid acting insulin.