Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart and Insulin Detemir.

In this study the medicine insulin degludec is compared to another medicine called insulin detemir.

Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance.

It had two arms (groups): Insulin Degludec (experimental) and Insulin Determir (active comparator).

Insulin Degludec once daily and Insulin Aspart 2-4 times daily.

Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 225 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2017-11-22 with completion listed for 2020-12-17.

It ran at 71 sites in United Kingdom (10), Canada (9), Russia (8), Australia (7), Argentina (6) and Brazil (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery (time frame: From GW 16 to GW 36).

It also tracked 23 secondary outcomes, for example Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals), Last Planned Fasting Plasma Glucose Prior to Delivery, Number of Hypoglycaemic Episodes During the Pregnancy Period, Number of Adverse Events During Pregnancy Period, Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery and Birth Weight for Live Birth Infants.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 225 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.