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 4
Laboratory parameters at week 6 and week 12.
| | 5-ALA-SFC | Placebo | | Mean | Change from baseline Mean (SE) | | Mean | Change from baseline Mean (SE) |
| Total cholesterol (mg/dL) | | | | | | | Week 6 | 27 | 166.9 | −5.2 (3.7) | 13 | 150.3 | −7.6 (5.5) | Week 12 | 25 | 181.4 | 6.8 (3.5) | 13 | 160.2 | −0.1 (5.0) |
| LDL cholesterol (mg/dL) | | | | | | | Week 6 | 27 | 109.4 | −2.9 (3.2) | 13 | 92.4 | −11.8 (4.7) | Week 12 | 25 | 121.4 | 7.6 (3.3) | 13 | 101.2 | −4.0 (4.6) |
| HDL cholesterol (mg/dL) | | | | | | | Week 6 | 27 | 40.2 | −0.8 (1.0) | 13 | 37.0 | −1.6 (1.4) | Week 12 | 25 | 41.9 | 0.5 (1.0) | 13 | 37.4 | −1.1 (1.4) |
| Triglycerides (mg/dL) | | | | | | | Week 6 | 27 | 156.6 | −1.3 (14.6) | 13 | 150.4 | 4.5 (21.1) | Week 12 | 25 | 163.9 | 3.2 (11.1) | 13 | 159.0 | 11.9 (15.4) |
| BUN (mg/dL) | | | | | | | Week 6 | 25 | 14.05 | 1.19 (0.573) | 11 | 13.42 | −0.43 (0.665) | Week 12 | 26 | 13.87 | 1.28 (0.606) | 12 | 13.00 | −0.54 (0.816) |
| Serum creatinine (mg/dL) | | | | | | | Week 6 | 28 | 0.96 | 0.01 (0.021) | 13 | 1.04 | −0.01 (0.023) | Week 12 | 26 | 0.96 | −0.00 (0.016) | 13 | 1.06 | 0.01 (0.026) |
| Ferritin (mg/dL) | | | | | | | Week 6 | 26 | 169.03 | 31.12 (9.480) | 12 | 136.48 | −12.59 (9.033) | Week 12 | 22 | 148.71 | 16.64 (11.289) | 12 | 137.54 | −11.53 (14.456) |
| Serum iron (mg/dL) | | | | | | | Week 6 | 27 | 18.16 | 0.87 (1.330) | 12 | 16.14 | −2.27 (1.502) | Week 12 | 22 | 17.73 | 1.41 (1.409) | 12 | 16.74 | −1.67 (1.083) |
| Transferrin saturation (%) | | | | | | | Week 6 | 25 | 31.38 | 3.77 (2.960) | 12 | 28.48 | −3.43 (2.562) | Week 12 | 21 | 29.93 | 3.37 (2.638) | 12 | 29.55 | −2.36 (1.753) |
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Compared to baseline mean for only the subjects with a result for the visit.
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