Faster-acting insulin aspart was safe for pregnant women with type 1 or 2 diabetes and resulted in fewer events of hypoglycemia, the randomized CopenFast trial found.
The mean infant birthweight standard deviation (SD) score was 1.0 in the faster-acting insulin aspart group versus 1.2 in the regular insulin aspart group (P=0.23), reported Lene Ringholm, PhD, of the Center for Pregnant Women with Diabetes at the University of Copenhagen in Denmark, during the European Association for the Study of Diabetes annual meeting.
On top of meeting the primary endpoint, women using faster-acting insulin aspart were less likely to have mild hypoglycemia at week 33 of pregnancy compared with those using regular insulin aspart (number of weekly mild events -0.90, 95% CI -1.71 to -0.09, P=0.030), the researchers pointed out in The Lancet Diabetes & Endocrinology, where the study was simultaneously published.
"Our results show that there is a benefit, particularly regarding the women who have problems with hypoglycemia unawareness and a history of severe hypoglycemia because we just don't see so much severe hypoglycemia with the faster aspart," Ringholm said, adding that women who are planning to become pregnant should consider making the switch. "It's typically optimal to change medication before pregnancy, more so when it comes to insulin."
She suggested that clinicians should have this discussion with their patients during the pre-pregnancy planning process.
In an accompanying commentary, Denice Feig, MD, MSc, of the University of Toronto in Canada, said that the inclusion of women with type 2 diabetes "may have diluted the findings," since women with type 1 diabetes are more likely to have poor glycemic control, glycemic variability, and greater risk for hypoglycemia and adverse pregnancy outcomes.
"The safety data should be reassuring to clinicians considering the use of faster aspart during pregnancy and adds to the several trials to date looking at other insulin analogues in pregnancy with reassuring results," Feig wrote.
In the current study, only one patient using faster-acting insulin aspart experienced a severe hypoglycemic episode, but there were 10 events in the conventional insulin aspart group (estimated treatment difference -0.08, 95% CI -0.16 to -0.01, P=0.026). The number needed to treat with faster insulin aspart to prevent one case of severe hypoglycemia was 18.
Overall, there were no significant differences in the number of adverse events or serious adverse events between the groups. None of the patients experienced diabetic ketoacidosis.
Ringholm explained that fetal overgrowth is common in pregnant women with either type of diabetes, though more common in type 1. However, severe hypoglycemia is a major concern during pregnancy, often hindering strict glycemic control.
This open-label study was conducted at Rigshospitalet in Copenhagen from November 2019 to May 2022, and randomized 203 pregnant women (average age 32) 1:1 to the two groups between weeks 8 and 13 of gestation; 72% had type 1 diabetes and 28% had type 2 diabetes. Most were on multiple daily injections at baseline, with an average daily insulin dose of 37 IU.
Disclosures
The trial was funded by Novo Nordisk.
Ringholm reported a financial relationship with Novo Nordisk.
Feig reported an honorarium for a podcast from Novo Nordisk.
Primary Source
The Lancet Diabetes & Endocrinology
Source Reference: Nørgaard SK, et al "Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial" Lancet Diabetes Endocrinol 2023; DOI: 10.1016/ S2213-8587(23)00236-X.
Secondary Source
The Lancet Diabetes & Endocrinology
Source Reference: Feig DS "Faster and faster: meeting the challenges of delayed insulin action during pregnancy" Lancet Diabetes Endocrinol 2023; DOI: 10.1016/ S2213-8587(23)00259-0.
