B M Bonora1, A Avogaro1, G P Fadini2. 1. Division of Metabolic Diseases, Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy. 2. Division of Metabolic Diseases, Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy. gianpaolo.fadini@unipd.it.
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.
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.
Entities:
Keywords:
Analogues; Insulin; Pregnancy; Type 1 diabetes
Authors: Martin Alcala; Victoria E Bolado; Isabel Sánchez-Vera; Sonia Clapés; Francisco Dasí; Guillermo Sáez; Esther Carrera; Fabiola Alvarez-Gallego; Mary R Loeken; Marta Viana Journal: Antioxidants (Basel) Date: 2021-07-23