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
MeanChange from baseline
Mean (SE)
MeanChange from baseline
Mean (SE)

Total cholesterol (mg/dL)
 Week 627166.9−5.2 (3.7)13150.3−7.6 (5.5)
 Week 1225181.46.8 (3.5)13160.2−0.1 (5.0)

LDL cholesterol (mg/dL)
 Week 627109.4−2.9 (3.2)1392.4−11.8 (4.7)
 Week 1225121.47.6 (3.3)13101.2−4.0 (4.6)

HDL cholesterol (mg/dL)
 Week 62740.2−0.8 (1.0)1337.0−1.6 (1.4)
 Week 122541.90.5 (1.0)1337.4−1.1 (1.4)

Triglycerides (mg/dL)
 Week 627156.6−1.3 (14.6)13150.44.5 (21.1)
 Week 1225163.93.2 (11.1)13159.011.9 (15.4)

BUN (mg/dL)
 Week 62514.051.19 (0.573)1113.42−0.43 (0.665)
 Week 122613.871.28 (0.606)1213.00−0.54 (0.816)

Serum creatinine (mg/dL)
 Week 6280.960.01 (0.021)131.04−0.01 (0.023)
 Week 12260.96−0.00 (0.016)131.060.01 (0.026)

Ferritin (mg/dL)
 Week 626169.0331.12 (9.480)12136.48−12.59 (9.033)
 Week 1222148.7116.64 (11.289)12137.54−11.53 (14.456)

Serum iron (mg/dL)
 Week 62718.160.87 (1.330)1216.14−2.27 (1.502)
 Week 122217.731.41 (1.409)1216.74−1.67 (1.083)

Transferrin saturation (%)
 Week 62531.383.77 (2.960)1228.48−3.43 (2.562)
 Week 122129.933.37 (2.638)1229.55−2.36 (1.753)

Compared to baseline mean for only the subjects with a result for the visit.