Safety of insulin analogues as compared with human insulin in pregnancy

ABSTRACT

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.

KEYWORDS:

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

Article highlights

• The safety of insulin analogues lispro, aspart and detemir, vs. human insulin has been studied extensively in pregnancy

• Insulin analogue therapy in pregnancy is as effective as human insulin. Yet, insulin detemir is superior to human insulin in lowering fasting blood glucose

• Use of those insulin analogues in pregnancy is considered safe, specifically lowering hypoglycaemia risk, as compared with human insulin

• Safety of insulin glargine therapy in pregnancy has been less investigated. However, its use is probably safe.

• Usually, administration of the analogues mentioned above during pregnancy was not associated with increased maternal, fetal and neonatal adverse outcomes

• Treatment with insulin glulisine and degludec in pregnancy is not recommended due to lack of safety data

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Declaration of interests

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.