Insulin aspart in patients with gestational diabetes mellitus and pregestational diabetes mellitus

AIMS: This study was undertaken to assess the effectiveness and safety of insulin aspart in patients with gestational and pregestational diabetes. SETTINGS AND DESIGN: An open-label, prospective, nonrandomized, comparative, and observational study conducted at single center in India. SUBJECTS AND METHODS: A total of 276 patients were in gestational diabetes mellitus (GDM) group, 79 were in the pre-GDM group. Patients were started on insulin therapy (insulin aspart ± neutral protamine hagedorn) 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. Insulin dose was titrated to keep the blood glucose values between 90 and 130 mg/dL. Patients were followed once every 4 weeks until the 28(th) week, then once every 2 weeks until 32(nd) week, then once every week until delivery, and the final visit was on 60 ± 7 days. The final outcome was assessed in terms of incidence of macrosomia (>3.5 kg body weight) between the two groups and episodes of confirmed (blood glucose <56 mg/dL) minor or major maternal hypoglycemia. RESULTS: There was no statistically significant difference among the two groups in terms of incidence of macrosomia that is., it was 5.1%, 8.9% in GDM, pre-GDM group, respectively. CONCLUSIONS: 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.