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Exposure to insulin degludec during pregnancy: report of a small series and review of the literature

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Abstract

Background

Good glycaemic control during pregnancy is key to reduce maternal and foetal complications. Insulin degludec, an ultralong acting analogue with a “peakless” and stable pharmacokinetic profile, has the potential advantage of reducing hypoglycaemia and glucose variability compared to other basal insulins. Therefore, degludec could be a reasonable therapeutic option for pregnant women with type 1 diabetes (T1D). However, degludec is not licensed for use during pregnancy owing to the lack of safety data.

Methods and results

We herein report details on pregnancy and foetal outcomes in three women with uncontrolled T1D treated with insulin degludec during the first trimester or the whole pregnancy. In addition, we report an updated review of similar cases reported in literature. Overall, no congenital neonatal malformation was observed in the six cases described. Three babies required neonatal intensive care unit admission for respiratory distress, apnoeas, bilirubin increase or hypoglycaemia. However, the observed neonatal complications were deemed unlikely to be related to degludec treatment.

Conclusions

In summary, while awaiting for the results of an ongoing randomized controlled trial, data on six cases of degludec exposure during pregnancy reassuringly suggest no embryo–foetal toxicity. More information is needed before degludec can be safely recommended during pregnancy.

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Authors and Affiliations

  1. Division of Metabolic Diseases, Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy

    B. M. Bonora, A. Avogaro & G. P. Fadini

Authors
  1. B. M. Bonora
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  2. A. Avogaro
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  3. G. P. Fadini
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Corresponding author

Correspondence to G. P. Fadini.

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Conflict of interest

GPF received grant support, lecture or advisory board fees from AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Genzyme, Abbott, Novartis and Merck Sharp & Dohme. FD received grants from AstraZeneca, Novo Nordisk and Boehringer-Ingelheim. AA received research grants, lecture or advisory board fees from Merck Sharp & Dome, AstraZeneca, Novartis, Boehringer-Ingelheim, Sanofi, Mediolanum, Janssen, Novo Nordisk, Lilly, Servier and Takeda. BMB declares no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Bonora, B.M., Avogaro, A. & Fadini, G.P. Exposure to insulin degludec during pregnancy: report of a small series and review of the literature. J Endocrinol Invest 42, 345–349 (2019). https://doi.org/10.1007/s40618-018-0926-9

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  • DOI: https://doi.org/10.1007/s40618-018-0926-9

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