Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes

Last updated: May 4, 2023
Sponsor: Rigshospitalet, Denmark
Overall Status: Completed

Phase

3

Condition

Pregnancy Complications

Diabetes And Hypertension

Diabetes Prevention

Treatment

Faster-acting Aspart insulin Fiasp

Control (insulin Novorapid)

Clinical Study ID

NCT03770767
U1111
  • Ages 18-65
  • Female

Study 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

Study Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: Faster-acting Aspart insulin Fiasp
Phase: 3
Study Start date:
November 11, 2019
Estimated Completion Date:
March 23, 2023

Connect with a study center

  • Center for Pregnant Women with Diabetes, Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

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