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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00365170Tipo: INTERVENTIONALInicio: 1 de sept de 2002Fin estimado: 1 de abr de 2005

Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

human insulin

drug

insulin aspart

Ubicaciones

Novo Nordisk Investigational Site

Ciudad de Buenos Aires, Argentina

Novo Nordisk Investigational Site

Pcia de Cordoba, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Randomised, Parallel-group, Open-label, Multinational T... | EligiMed