Objective: To study the efficacy and safety of glibenclamide/metformin combination as a treatment option for pregnant women with either gestational diabetes or type-2 diabetes mellitus compared to conventional insulin therapy.
Methods: Eighty-four pregnant women with singleton pregnancies (65 women with gestational diabetes & 19 with type-2 diabetes mellitus) were included. They were randomly allocated to receive either glibenclamide/metformin combination or insulin. The primary end point was the achievement of the desired level of glycemic control. The presence or absence of maternal, fetal and/or neonatal complications was measured as secondary end points.
Results: There were no differences between the oral hypoglycemic-treated group and insulin-treated group as regard the mean blood glucose levels. It was 125.64 ± 18.15 mg/dL in the former group where it was 124.62 ± 9.29 mg/dL in the latter one. There was no significant difference as regard the amniotic fluid volume, gestational age at delivery and mode of delivery. Also, there were no significant difference between the two groups as regard fetal outcomes; the perinatal mortality was 7.1% in oral hypoglycemic group compared to 4.8% in insulin group, and the rate of congenital anomalies was 4.9% in oral group compared to 9.5% in insulin group. Also there was no statistically significant difference as regard neonatal birth weight, neonatal umbilical blood glucose, incidence and duration of admission to NICU.
Conclusion: The treatment of gestational diabetes and type-2 diabetes mellitus pregnant ladies with Glibenclamide/ metformin combination or insulin seems to be equivalent for both the mother and newborns.