Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.

It had two arms (groups): Intervention with insulin Fiasp (experimental) and Control (insulin Novorapid) (active comparator).

Women randomized to insulin Fiasp.

Women randomized to insulin NovoRapid.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 216 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Women, age ≥ 18 years. Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months. Type 2 diabetes (any duration). Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks. Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality.

The full record lists 8 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2019-11-11 with completion listed for 2023-03-23.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Birth weight standard deviation score (time frame: At delivery).

It also tracked 12 secondary outcomes, for example HbA1c levels, Postprandial self-monitoring of plasma glucose (SMPG) levels, Preprandial self-monitoring of plasma glucose (SMPG) levels, Continuous glucose monitoring data, Severe hypoglycemia and Mild hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 216 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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