Skip to main content
OpenTrials
Completed

NCT Number: NCT00365170

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Ciudad de Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human insulin

Drug

insulin aspart

Drug

Primary outcomes

  1. Relative risk of major maternal hypoglycaemia

    Time frame: after 24 hours

Secondary outcomes

  1. Relative risk of major and minor hypoglycaemia

  2. Diabetic complications

  3. Obstetric complications

  4. Other Adverse Events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Aug 17, 2006
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.