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

Fasting plasma glucose (mg/dL)
 Week 233145.12.3 (3.4)14138.4−7.3 (5.2)
 Week 430142.1−0.2 (4.9)14145.6−0.8 (7.2)
 Week 627138.0−4.8 (3.2)13132.4−9.2 (4.7)
 Week 822135.8−4.5 (4.0)12142.7−1.0 (5.5)
 Week 1023140.3−0.9 (5.6)12143.1−0.9 (7.8)
 Week 1222139.3−3.0 (4.4)12139.5−4.2 (5.9)

Plasma glucose 2 hours after meal (mg/dL)
 Week 233189.6−0.2 (5.1)14166.3−26.5 (7.8)
 Week 430175.7−12.9 (6.1)12173.9−18.8 (9.9)
 Week 627173.4−14.5 (5.4)13158.5−27.4 (7.8)
 Week 820176.2−5.6 (5.6)11155.0−30.5 (11.2)
 Week 1020175.1−10.3 (10.5)12181.2−7.6 (13.5)
 Week 1221175.0−8.5 (9.8)10154.3−33.0 (14.2)

< 0.05 between groups.
Compared to baseline mean for only the subjects with a result for the visit.