Insulin Glulisine in Pregnancy – Experience from Clinical Trials and Post-marketing Surveillance

Abstract

Pregnancies complicated by gestational diabetes or pre-existing type 1 or type 2 diabetes mellitus are associated with a higher rate of adverse outcomes compared with pregnancies in the background population. These outcomes include miscarriage, pre-term delivery, pre-eclampsia, perinatal mortality and congenital malformations. Insulin glulisine (Apidra®, Sanofi) is a rapid-acting insulin analogue indicated for the treatment of adults, adolescents and children 6 years or older with diabetes mellitus where treatment with insulin is required. Here, all post-marketing and clinical trials safety data with insulin glulisine in pregnancy available to Sanofi up to June 2014 are summarised together with the findings of a comprehensive literature search. Cumulatively, a total of 303 pregnancy exposures to insulin glulisine were received. Of these 303 pregnancy exposures, there were 116 live births, 12 spontaneous abortions, two late foetal intra-uterine deaths (>28 weeks), three elective abortions and 170 cases without a known pregnancy outcome. There were six cases of congenital malformations; of these, there were five live births; in the other case a live birth was not confirmed. The congenital malformations reported to date do not reveal a pattern of defects. In conclusion, the evidence to date does not suggest a causal association between insulin glulisine and an increased risk of pregnancy complications or congenital malformations.

Diabetes and Pregnancy

“…A meta-analysis of randomized trials of 1,143 women with gestational or pre-existing diabetes assessing the use of insulin aspart or premixed biphasic insulin aspart 30 compared to human regular insulin or premixed biphasic insulin aspart during pregnancy found similar rates of caesarean section and macrosomia (135). Finally, a case series of 303 women exposed to glulisine during pregnancy showed no noted pattern of few birth defects (137). There are no data to date on faster-acting insulin aspart.…”

Diabetes: how to manage gestational diabetes mellitus

“…Of the 303 pregnancy exposures, the analysis of the data did not suggest a causal association between insulin glulisine use and congenital malformations. 17 Additionally, a small randomized clinical trial of 16 women with GDM comparing NPH insulin to insulin glulisine was conducted. 18 The mean gestational age of the women was 30.3 weeks and they were followed until delivery.…”

Gravidität bei vorbestehendem Diabetes (Update 2019)

“…Das ultraschnell-wirksame Insulin Aspart (Fiasp ® ) ist in der Schwangerschaft ebenso zugelassen. Für Glulisin liegen in der Gravidität derzeit nur Vigilanzdaten vor [22], die keine besonderen Auffälligkeiten zeigen. Aufgrund der schlechten Datenlage wird eine Anwendung in der Schwangerschaft nicht empfohlen.…”