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Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes | Clinical Trials | Clareo Health

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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

NCT00365170•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

Locations (95)

Novo Nordisk Investigational Site

Ciudad de Buenos Aires, Argentina

Novo Nordisk Investigational Site

Pcia de Cordoba, Argentina

Novo Nordisk Investigational Site

Graz, Austria

Novo Nordisk Investigational Site

Salzburg, Austria

Novo Nordisk Investigational Site

Vienna, Austria

Novo Nordisk Investigational Site

Vienna, Austria

Novo Nordisk Investigational Site

Sofia, Bulgaria

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Novo Nordisk Investigational Site

Ottawa, Canada

Novo Nordisk Investigational Site

St. John's, Canada

Key Dates

Start Date

September 1, 2002

Primary Completion Date

April 1, 2005

Completion Date

April 1, 2005

Last Updated

December 21, 2016

Enrollment

419

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1

Interventions

human insulin

DRUG

insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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