Insulin degludec as good as insulin detemir for blood sugar control in pregnant women with type 1 diabetes

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