Type 1 diabetes and pregnancy: two insulins compared
New research presented at the latest EASD conference compared two different insulins in pregnancy for women with type 1 diabetes. Lisa Buckingham reports.
Poor glycaemic control in women with type 1 diabetes is related to poor pregnancy outcomes. Achieving good diabetic control is therefore extremely important in pregnant women with type 1 diabetes – a point Professor Elisabeth Mathiesen (University of Copenhagen, Denmark) was at pains to emphasise in the course of her presentation of results from the international, multi-centre, randomised, treat-to-target trial, EXPECT (sponsored by Novo Nordisk).
While insulin degludec has a well-established efficacy and safety profile outside of pregnancy, there is limited information from within pregnancy. The EXPECT trial evaluated the efficacy and safety of insulin degludec versus insulin detemir in pregnant women with diabetes. It included both pregnant and non-pregnant women. Those who were pregnant were required to have had type 1 diabetes for at least a year and to be in week 8-14 of gestation. They were randomised to either degludec plus insulin aspart 2-4 times daily or detemir plus insulin aspart 2-4 times daily. They were monitored throughout pregnancy and at 28 days after delivery.
They were also able to include women who were planning to become pregnant, and they were randomised to one of the two insulins. A proportion of them became pregnant during study and were then observed in the same way as the pregnant women.
Professor Mathiesen showed the baseline data for each group of pregnant women, which was similar in both groups. For example, age was 30.7 for degludec and 30.9 for detemir, with HbA1c of 6.6% and 6.5%, respectively.
The first of the results presented was HbA1c throughout pregnancy. HbA1c was similar throughout in both groups and Professor Mathiesen highlighted the estimated mean HbA1c at the last planned visit – 6.34% for detemir and 6.23% for degludec. This was a major outcome of the study.
They also looked at the prevalence of hypoglycaemia. The majority of the women had hypoglycaemia, including nocturnal hypoglycaemia, but the rate of severe hypoglycaemia was low in both groups. Overall, the hypoglycaemia rates were numerically lower with insulin degludec but there was no clinically significant difference in the risk of hypoglycaemia between the two groups.
Rates of pre-eclampsia and adverse events (AE) were also studied. Prevalence of pre-eclampsia was 14% in the degludec group and 8.2% in the detemir group but a post hoc analysis found that this was not clinically significant. The majority of the women experienced at least one AE and it was 85.7% in the degludec group and 80.9% in the detemir group. For serious AEs, it was 41.8% for degludec and 34.0% for detemir. No AEs led to participant discontinuation in the degludec treatment group and the high number included events such as acute caesarean section.
With regard to pregnancy outcomes, there were 86 liveborn infants in the degludec group and 85 in the detemir group. There were eight infants with major abnormalities in both groups.
Pre-term delivery of 37 weeks or less was 33.7% in the degludec group and 22.4% in the detemir group. Infants born large for gestational age was 64% for degludec and 50.6% for detemir. A post hoc analysis found no significant difference in each of these outcomes.
Infants with neonatal hypoglycaemia and adverse events after delivery were similar in both groups.
Professor Mathiesen concluded that, in pregnant women with type 1 diabetes, insulin degludec was non-inferior to insulin detemir with respect to HbA1c, prior to delivery. Pregnancy outcomes and safety profiles for both women with type 1 diabetes and their foetuses/infants were comparable between insulin degludec and insulin detemir.
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Any opinions expressed in this article are the responsibility of the EASD e-Learning Programme Director, Dr Eleanor D Kennedy.
Webcasts from the EASD’s 2021 virtual meeting are now available free to all on the EASD website.
To view Professor Mathiesen’s presentation, go to: https://www.easd.org/virtualmeeting/home.html#!resources/b-maternal-efficacy-safety-and-pregnancy-outcomes-with-degludec-vs-detemir-in-the-treatment-of-pregnant-women-with-type-1-diabetes-an-international-multicentre-randomised-trial-b
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