Clinical Study
The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain
Table 5
Change in mean HbA1c during dosing period (ITT and PP populations).
| | | 5-ALA-SFC | Placebo | | | | Mean | Change from baseline
Mean (SE) | | Mean | Change from baseline
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) |
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< 0.05 compared to baseline.
Compared to baseline mean for only the subjects with a result for the visit.
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