Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Insulin Aspart.

This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

The registry classes the interventions as drug.

Who Took Part

419 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.

Examples of who could join: Type 1 diabetes. Treated with insulin for at least 12 months. Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: previous birth of child with a major congenital malformation; more than 2 previous multiple miscarriages or stillbirths; severe hyperemesis gravidarum, requiring hospitalisation, according to investigator judgement.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2002-09 with completion listed for 2005-04.

It ran at 95 sites in United Kingdom (27), France (14), Poland (8), Canada (7), Netherlands (7) and Austria (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative risk of major maternal hypoglycaemia (time frame: after 24 hours).

It also tracked 4 secondary outcomes, for example Relative risk of major and minor hypoglycaemia, Diabetic complications, Obstetric complications and Other Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 419 people.

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

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.