Safety of insulin analogues as compared with human insulin in pregnancy

Yoel Toledano, Eran Hadar, Moshe Hod*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review


Introduction: Diabetes during pregnancy may lead to maternal, fetal and neonatal complications. In order to limit unwarranted outcomes, strict glycemic control is essential. In the past, human insulin was the only insulin formulation administered in pregnancy. However, insulin analogues have also been used for this indication in recent years. Areas covered: This article reviews the published data regarding the safety of insulin analogue use during pregnancy. We present the qualities, advantages and pitfalls of insulin analogue use in pregnancy compared with human insulin. Insulins lispro, aspart and detemir are safe in pregnant women with type 1 diabetes. Correspondingly, they were reclassified for the treatment of pregnant women with diabetes from category C to category B. For insulin glargine use in pregnancy, most studies are small and retrospective. Yet, no major safety concerns were reported. Insulin glulisine and degludec have not been studied in pregnancy. Expert opinion: Insulin analogues are viable therapeutic options for diabetes in pregnancy, specifically lispro, aspart and detemir. Though data in limited, their safety and efficacy are comparable with human insulin. Remarkably, the analogues are superior to human insulin regarding hypoglycaemia risk. More data, specifically for their use in pregnancies complicated by gestational diabetes or type 2 diabetes, is needed.

Original languageEnglish
Pages (from-to)963-973
Number of pages11
JournalExpert Opinion on Drug Safety
Issue number7
StatePublished - 2 Jul 2016
Externally publishedYes


  • Aspart
  • detemir
  • diabetes mellitus
  • glargine
  • glulisine
  • insulin
  • lispro
  • perinatal outcomes
  • pregnancy
  • safety


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