Insulin degludec is a second-generation basal insulin with an improved pharmacokinetic–pharmacodynamic profile versus the first-generation basal insulins. Still, there is not much data regarding its use during pregnancy. Prof Elisabeth R Mathiesen from the University of Copenhagen, Copenhagen, Denmark, and colleagues, therefore, aimed to compare the safety and efficacy of detemir with degludec, both in combination with insulin aspart (aspart), in pregnant women with type 1 diabetes.
EXPECT, a multinational, open-label, controlled, randomized, non-inferiority trial, was conducted at 56 sites (medical centers and hospitals) in 14 countries. It included women aged at least 18 years with type 1 diabetes with a gestational age of eight weeks (+0 days) and 13 weeks (+6 days) or planned to become pregnant. They were randomly assigned in the ratio of 1:1 to once daily degludec (100 U/mL) or once or twice daily detemir (100 U/mL), both with mealtime insulin aspart (100 U/mL), all via subcutaneous injection.
Pregnant participants received the trial drug at randomization throughout pregnancy until 28 days after delivery (end of treatment). Participants who were not pregnant at randomization initiated the trial drug before conception. The last planned HbA1c measurement before delivery was determined (primary endpoint). Secondary endpoints included maternal safety, efficacy, and pregnancy outcomes.
The primary endpoint was evaluated in all randomly assigned pregnant participants during the trial. Safety assessment was done in all randomly assigned participants who had pregnancy during the trial and were exposed to at least some trial drug dose.
The study revealed the following findings:
· 225 women from 296 women screened were randomly assigned to detemir (n=114) or degludec (n=111) between 2017 to 2019, from 296 women screened.
· In the degludec group, mean HbA1c at pregnancy baseline was 6·6% and 6·5% in the detemir group.
· In the degludec group, the mean last planned HbA1c measurement before delivery was 6·2% and 6·3% in the detemir group (estimated treatment difference −0·11%; −1·2 mmol/mol), confirming non-inferiority.
· No additional safety issues were seen with degludec compared with detemir.
"Degludec was shown to be non-inferior to detemir in pregnant women with type 1 diabetes," the researchers concluded.
Reference:
The study titled, "Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomized, controlled, non-inferiority trial," was published in The Lancet Diabetes & Endocrinology. DOI: https://doi.org/10.1016/S2213-8587(22)00307-2
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