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 6
Mean and change from baseline in fasting plasma glucose and plasma glucose 2 hours after breakfast (ITT population).
| | 5-ALA-SFC | Placebo | | Mean | Change from baseline Mean (SE) | | Mean | Change from baseline Mean (SE) |
| Fasting plasma glucose (mg/dL) | | | | | | | Week 2 | 33 | 145.1 | 2.3 (3.4) | 14 | 138.4 | −7.3 (5.2) | Week 4 | 30 | 142.1 | −0.2 (4.9) | 14 | 145.6 | −0.8 (7.2) | Week 6 | 27 | 138.0 | −4.8 (3.2) | 13 | 132.4 | −9.2 (4.7) | Week 8 | 22 | 135.8 | −4.5 (4.0) | 12 | 142.7 | −1.0 (5.5) | Week 10 | 23 | 140.3 | −0.9 (5.6) | 12 | 143.1 | −0.9 (7.8) | Week 12 | 22 | 139.3 | −3.0 (4.4) | 12 | 139.5 | −4.2 (5.9) |
| Plasma glucose 2 hours after meal (mg/dL) | | | | | | | Week 2 | 33 | 189.6 | −0.2 (5.1) | 14 | 166.3 | −26.5 (7.8) | Week 4 | 30 | 175.7 | −12.9 (6.1) | 12 | 173.9 | −18.8 (9.9) | Week 6 | 27 | 173.4 | −14.5 (5.4) | 13 | 158.5 | −27.4 (7.8) | Week 8 | 20 | 176.2 | −5.6 (5.6) | 11 | 155.0 | −30.5 (11.2) | Week 10 | 20 | 175.1 | −10.3 (10.5) | 12 | 181.2 | −7.6 (13.5) | Week 12 | 21 | 175.0 | −8.5 (9.8) | 10 | 154.3 | −33.0 (14.2) |
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< 0.05 between groups. Compared to baseline mean for only the subjects with a result for the visit.
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