Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes
Status and phase
Completed
Phase 4
Conditions
Diabetes Mellitus, Type 1
Diabetes
Treatments
Drug: human insulin
Drug: insulin aspart
Details and patient eligibility
About
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.
Enrollment
419 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
95
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Data sourced from clinicaltrials.gov
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