Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00365170
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 419
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relative risk of major maternal hypoglycaemia after 24 hours
- Secondary Outcome Measures
Name Time Method Other Adverse Events Diabetic complications Obstetric complications Relative risk of major and minor hypoglycaemia
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Worcester, United Kingdom