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

• Main Authors: M C Deepaklal, Kurian Joseph, Kurian Rekha, Thakkar Nandita
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2015-01-01
• Series: Indian Journal of Endocrinology and Metabolism
• Subjects: Gestational diabetes mellitus; insulin aspart; pregestational diabetes mellitus
• Online Access: http://www.ijem.in/article.asp?issn=2230-8210;year=2015;volume=19;issue=5;spage=658;epage=662;aulast=Deepaklal

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.