Status:
COMPLETED
Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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®) ver...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00365170
Start Date
September 1 2002
End Date
April 1 2005
Last Update
December 21 2016
Active Locations (95)
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1
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, Argentina, 1405
2
Novo Nordisk Investigational Site
Pcia de Cordoba, Argentina, 5000
3
Novo Nordisk Investigational Site
Graz, Austria, 8036
4
Novo Nordisk Investigational Site
Salzburg, Austria, 5020