Glibenclamide versus insulin in treatment of gestational diabetes mellitus – a randomised controlled trial

Background: One of the most serious consequences of pregnancy is Gestational diabetes mellitus (GDM). It has a negative impact on the mother and the newborn. Maintaining normal blood glucose levels in GDM lowers morbidity for both mother and infant. The first therapy for GDM consists of diet and exercise. If these approaches fail to reach glycemic objectives, medical management should be instituted, which may include insulin or oral hypoglycemic medications. Aim of the work: To determine the glibenclamide versus insulin efficacy in achieving the adequate glycemic control. Methods: This randomized control study was conducted on 120 pregnant women with gestational ages ranging from 20 to 37 weeks at Ain Shams University Maternity Hospital between July 2018 and June 2019, using inclusion and exclusion criteria. Results: Regarding to the glycemic control, there was no significant difference in mean glucose levels at enrollment time before treatment between the two groups as fasting glucose levels were 139.1±12.5 mg/dl in Glibenclamide treated group versus 138.9±11.9 mg/dl in insulin treated group (p=0.650) and 2-hours postprandial glucose levels were 194.8±31.1 in Glibenclamide treated group versus 192.1±28.4 mg/dl in insulin treated group (p=0.625). Regarding postprandial blood glucose after introduction of the drugs, there was no significant differences between the studied groups after one week, at follow-up levels and till delivery time. The uncontrolled cases of Glibenclamide treated group mostly shift to insulin in weeks 4 and 5 after introduction of the drug. Regarding mode of delivery, Cesarean delivery was non-significantly less frequent in Glibenclamide group. 53.3% of patients in Glibenclamide group underwent cesarean delivery versus 61.7% in insulin group (p value=0.356). maternal complications of hypoglycemia were significantly less frequent in Glibenclamide group (p value =0.027) and GIT upset was significantly more frequent in Glibenclamide group (p value =0.032) while Polyhydramnios was non-significantly more frequent in Glibenclamide group (p value=0.491). Regarding neonatal outcome, neonatal birth weight was significantly lower in Glibenclamide group (Glibenclamide 3.3±0.3 kg versus 3.5±0.4 kg in insulin group, p value=0.006). In terms of newborn problems, fetal macrosomia, newborn hypoglycemia, RDS, NICU hospitalization, and congenital anomalies did not significantly differ between the two groups. Conclusion: Glibenclamide appears to be an effective medicine in the treatment of pregnant women with GDM, maintaining appropriate glycemic control with decreased risk of hypoglycemia and with maternal and newborn morbidities equivalent to insulin. The therapy is significantly less expensive; nonetheless, further appropriately powered and randomized clinical trials, including long-term child follow-up, are needed to establish the relevance of glibenclamide as an alternative to insulin in the management of GDM in women.