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

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart and Insulin Detemir.

Who Took Part

The age groups tagged for this paper are infants, teenagers and adults, women only.

Women aged at least 18 years with type 1 diabetes who were between gestational age 8 weeks (+0 days) and 13 weeks (+6 days) or planned to become pregnant were randomly assigned (1:1), via an interactive web response system, to degludec (a set amount) once daily or detemir (a set amount) once or twice daily, both with mealtime insulin aspart (a set amount), all via subcutaneous injection.

Participants who were pregnant received the trial drug at randomisation, throughout pregnancy and until 28 days post-delivery (end of treatment).

How the Study Was Run

In design terms this was a randomized and open-label study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Participants not pregnant at randomisation initiated the trial drug before conception.

The primary endpoint was assessed in all randomly assigned participants who were pregnant during the trial.

This study is registered with ClinicalTrials.gov, NCT03377699, and is now completed.

What Was Measured

The subject headings attached to it are Insulin Aspart, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Insulin Detemir, Pregnant People, Diabetes Mellitus, Type 2 and Blood Glucose.

What This Means in Plain Language

The paper is a randomized and open-label study of Insulin Aspart and Insulin Detemir.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2023 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page.