Table 5.
Change in mean HbA1c during dosing period (ITT and PP populations).
| 5-ALA-SFC | Placebo | |||||
|---|---|---|---|---|---|---|
| n | Mean | Change from baselinea
Mean (SE) |
n | Mean | Change from baselinea
Mean (SE) |
|
| Intent-to-treat population | ||||||
| Week 2 | 32 | 7.6 | −0.2∗ (0.1) | 13 | 7.4 | −0.5∗ (0.2) |
| Week 4 | 30 | 7.5 | −0.3∗ (0.1) | 13 | 7.3 | −0.5∗ (0.2) |
| Week 6 | 28 | 7.3 | −0.4∗ (0.1) | 13 | 7.2 | −0.6∗ (0.2) |
| Week 12 | 25 | 7.1 | −0.7∗ (0.2) | 13 | 7.3 | −0.5 (0.2) |
|
| ||||||
| Per protocol population | ||||||
| Week 2 | 15 | 7.3 | −0.3∗ (0.1) | 6 | 7.6 | −0.3 (0.2) |
| Week 4 | 15 | 7.1 | −0.4∗ (0.1) | 7 | 7.3 | −0.5 (0.2) |
| Week 6 | 14 | 7.1 | −0.4∗ (0.1) | 7 | 7.2 | −0.6 (0.2) |
| Week 12 | 14 | 6.8 | −0.8∗ (0.2) | 7 | 7.3 | −0.5 (0.3) |
∗ p < 0.05 compared to baseline.
aCompared to baseline mean for only the subjects with a result for the visit.