Table 2.
Key Outcomes From Baseline to Week 12 and Week 24.
| Variable | Baseline | Week 12 | Week 24 | P-value for trend |
|---|---|---|---|---|
| HbA1c, % HbA1c, mmol/mol |
9.8 (0.9) 83.7 (10.2) |
8.2 (0.9)
a
66.3 (10.3) a |
8.1 (0.9)
b
64.6 (9.8) b |
<.001 <.001 |
| Proportion-in-range, % (70-180 mg/dL, 3.9-10 mmol/L) | 58.8 (22) | 64.7 (20.8) a | 67.1 (21.6) b | .001 |
| Proportion-above-range, % (>180 mg/dL, >10 mmol/L) | 39 (22.7) | 33.7 (21.7) a | 31.3 (21.9) b | .005 |
| Proportion-below-range, % (<70 mg/dL, <3.9 mmol/L) | 0 (0, 2.6) | 0 (0, 2.3) | 1.3 (0, 2.3) | .540 |
| Coefficient of variation (CV), % | 32.9 (7.7) | 29.9 (7.3) a | 30.7 (7.6) b | <.001 |
| TDD of insulin (units/kg/d) | 0.80 (0.65, 0.97) | 0.82 (0.66, 1.1) | 0.84 (0.67, 1.1) b | .007 |
| TDD of basal insulin (units/kg/d) | 0.41 (0.35, 0.51) | 0.43 (0.33, 0.52) | 0.43 (0.33, 0.56) b | .112 |
| TDD of bolus insulin (units/kg/d) | 0.39 (0.28, 0.50) | 0.43 (0.28, 0.57) a | 0.40 (0.30, 0.53) b | <.001 |
| Body mass index, kg/m2 | 27.8 (4.3) | 28.2 (4.5) a | 28.2 (4.3) b | .008 |
| Body weight, kg | 74 (15.2) | 74.6 (15) a | 74.9 (15.2) b | .012 |
All data reported as mean (SD) except proportion below range and total daily doses of insulins reported as median (25th centile, 75th centile).
Abbreviations: CV, coefficient of variation; TDD, total daily dose; SD, standard deviation.
a
P < .05, baseline versus week 12.
b
P < .05, baseline versus week 24.
P < .05, week 12 versus week 24.