Status:
COMPLETED
Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Diabetes Mellitus
Pregnancy Complications
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Women, age ≥ 18 years
- Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months
- Type 2 diabetes (any duration)
- Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
- Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality
- Women with type 1 diabetes using an insulin pump compatible with trial products
- Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated
- Proficiency in Danish to understand oral and written information
- Exclusion criteria
- • Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
Exclusion
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2023
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03770767
Start Date
November 11 2019
End Date
March 23 2023
Last Update
May 6 2023
Active Locations (1)
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1
Center for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen, Denmark