Insulin Degludec non-inferior to detemir in pregnant women with T1D

This article entitled “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, randomised, controlled, non-inferiority trial” is published in The Lancet Diabetes and Endocrinology.

Prof Elisabeth R Mathiesen, MD, explaining the study background, said Insulin degludec (degludec) is a second-generation basal insulin. It has an improved pharmacokinetic–pharmacodynamic profile in comparison to first-generation basal insulins. She further noted that the data regarding its use in pregnant women is limited. We investigated the comparison of efficacy and safety of degludec with insulin detemir (detemir), both in combination with insulin aspart (aspart), in pregnant women with type 1 diabetes.

Knowing about EXPECT trial:

The trial was conducted in 14 countries at near about 56 sites. Women included were at least 18 years with T1D (between gestational ages eight weeks and 13 weeks or planned to become pregnant.

These were randomly assigned (111 women to degludec and 114 to Detemir) via an interactive web response system to degludec (100 U/mL) once daily or Detemir (100 U/mL) once or twice daily, both with mealtime insulin aspart (100 U/mL), all via subcutaneous injection.

The primary and secondary endpoints were the last planned HbA1c measurements before delivery and efficacy, maternal safety, and pregnancy outcomes, respectively.

Based on the Findings, the following conclusion can be drawn:

• At pregnancy baseline, Mean HbA1c was 6·6% and 6.5 % in the degludec and detemir groups, respectively.
• The mean last planned HbA1c measurement before delivery was 6·2% and 6.3 % in the degludec and detemir groups, respectively, with an estimated treatment difference of 0·11%, confirming non-inferiority.
• When Compared with Detemir, there were no additional safety concerns with degludec.

The researchers concluded that degludec is non-inferior to detemir in pregnant women with T1D.

As acknowledged, the study was funded by Novo Nordisk.

Further reading:

https://doi.org/10.1016/S2213-8587(22)00307-2