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

A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365170

Enrollment

419

Registered

2006-08-17

Start date

2002-09-30

Completion date

2005-04-30

Last updated

2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

DRUGhuman insulin

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 1 diabetes * Treated with insulin for at least 12 months * Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or * Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

Exclusion criteria

* 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 * Subjects being treated for infertility * Proliferative retinopathy or maculopathy requiring acute treatment * Drug or alcohol abuse * Impaired renal, hepatic or cardiac function

Design outcomes

Primary

Measure	Time frame
Relative risk of major maternal hypoglycaemia	after 24 hours

Secondary

Measure	Time frame
Relative risk of major and minor hypoglycaemia	—
Diabetic complications	—
Obstetric complications	—
Other Adverse Events	—

Countries

Argentina, Austria, Bulgaria, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Netherlands, Norway, Poland, Russia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026