Abstract
Aims: This study was undertaken to assess the effectiveness and safety of faster acting insulin aspart in patients with gestational diabetes. Though faster acting insulin aspart is approved to be used in pregnancy by regulatory bodies like USFDA, EMA and DCGI (India), no data is published till date on its usage in pregnancy. Settings and Design: An open-label, nonrandomized, and observational study conducted at single centre at Kolkata, India. Subjects and Methods: A total of 37 patients with gestational diabetes mellitus (GDM) were included in the analysis. Patients were started on insulin therapy (faster acting insulin aspart ± basal insulin) once medical nutrition therapy for 2 weeks failed to achieve control, that is., fasting plasma glucose ≥90 mg/dL and/or 1.0 h postprandial plasma glucose ≥130 mg/dL. Basal insulin dose was titrated to achieve a fasting of 90-100 and the Faster aspart was titrated to achieve a post-meal of 120 and not exceeding 130. Patients were followed once every 4 weeks until the 28th week, then once every 2 weeks until 32nd week, then once every week until delivery, and the final visit was on 30 ± 7 days after delivery of the child. Results: Out of 37 full term deliveries, only two had macrosomia. No congenital defects were noted in the anomaly scan and at births. There were no episodes of neonatal hypoglycemia reported. Only one episode of post-meal symptomatic maternal hypoglycemia was reported. Mean number of FiASP injections per day was 2.88 ± 0.39. Mean daily dose of FiASP used was 22.7 ± 6 international units. A total of 89% of the patients received faster aspart thrice daily and remaining received it twice daily. Conclusions: Faster acting insulin aspart was found safe in pregnancy, however, more studies with double-blind, standard controlled studies are required to confirm the findings of this study.
Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus
