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

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Pregnancy Complications; Diabetes Mellitus

Treatments: Drug: Faster-acting Aspart insulin Fiasp; Drug: Control (insulin Novorapid)

Study type: Interventional

Funder types: Other

Identifiers

NCT03770767

U1111

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Intervention with insulin Fiasp

Experimental group

Description:

Women randomized to insulin Fiasp

Treatment:

Drug: Faster-acting Aspart insulin Fiasp

Control (insulin Novorapid)

Active Comparator group

Description:

Women randomized to insulin NovoRapid

Treatment:

Drug: Control (insulin Novorapid)