A comparison of the faster-acting insulin Fiasp® versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation

A randomised controlled trial comparing the effect of the faster-acting insulin analog - insulin Fiasp® – versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004680-31-DK

Enrollment

220

Registered

2019-04-30

Start date

2019-08-16

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 and type 2 diabetes during pregnancy and lactation MedDRA version: 20.0 Level: LLT Classification code 10012614 Term: Diabetes mellitus NOS System Organ Class: 100000004861 MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Fiasp Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Concentration unit: U/ml unit(s)/millilitre Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women, age = 18 years Duration of type 1 diabetes = 12 months or type 2 diabetes (any duration) Pregnant with an intrauterine singleton living fetus (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator • Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or NPH insulin and not willing to continue routine treatment modality • Women with type 2 diabetes who before pregnancy were either treated with diet, oral antidiabetic therapy or pre-mixed insulin who are not willing to change to trial medication according to randomisation or to an appropriate long-acting insulin analog as insulin detemir, insulin degludec, insulin glargine, insulin abasaglar or insulin toujeo (as part of routine MDI therapy in type 2 diabetes), as indicated. • No proficiency in Danish to understand oral and written information

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to evaluate the effect of insulin Fiasp® compared to insulin NovoRapid®, both in combination with usual long-acting insulin when indicated, on postprandial glucose levels, HbA1c, prevalence of fetal overgrowth in women with type 1 or type 2 diabetes during pregnancy. Infant growth and health up to 3 months of age will also be evaluated. The incidence of mild and severe hypoglycemia and the potential of blinded CGM to predict fetal overgrowth will be evaluated. The most appropriate insulin pump settings during pregnancy and lactation will be explored. ;Secondary Objective: Not applicable;Primary end point(s): Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score);Timepoint(s) of evaluation of this end point: At birth	—

Measure

Time frame

Main Objective: The objective is to evaluate the effect of insulin Fiasp® compared to insulin NovoRapid®, both in combination with usual long-acting insulin when indicated, on postprandial glucose levels, HbA1c, prevalence of fetal overgrowth in women with type 1 or type 2 diabetes during pregnancy. Infant growth and health up to 3 months of age will also be evaluated. The incidence of mild and severe hypoglycemia and the potential of blinded CGM to predict fetal overgrowth will be evaluated. The most appropriate insulin pump settings during pregnancy and lactation will be explored. ;Secondary Objective: Not applicable;Primary end point(s): Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score);Timepoint(s) of evaluation of this end point: At birth

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Secondary

Measure	Time frame
Secondary end point(s): a. HbA1c levels in pregnancy and at end of pregnancy at 36 weeks b. Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy and at end of pregnancy at 36 weeks c. Preprandial SMPG levels in pregnancy and at end of pregnancy at 36 weeks d. The amount of time (minutes) during CGM use spent in the target area 4.0-7.0 mmol/l, with glucose 7.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively, in pregnancy e. The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first three months after giving birth f. Infant growth and health at three months of age g. The prevalence of fetal overgrowth, defined as the offspring birth weight SD score >90th percentile h. The prevalence of miscarriage, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death i. Neonatal morbidity (neonatal hypoglycemia, jaundice, respiratory distress and duration of stay in neonatal intensive care unit), mode of delivery (vaginal, cesarean section, instrumental delivery) j. Maternal gestational weight gain and weight retention three months after delivery We also aim to explore: k. In women on insulin pump therapy, appropriate insulin pump settings (mainly carbohydrate ratio and sensitivity) in pregnancy and during lactation ;Timepoint(s) of evaluation of this end point: From inclusion in early pregnancy until three months after delivery	—

Measure

Time frame

Secondary end point(s): a. HbA1c levels in pregnancy and at end of pregnancy at 36 weeks b. Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy and at end of pregnancy at 36 weeks c. Preprandial SMPG levels in pregnancy and at end of pregnancy at 36 weeks d. The amount of time (minutes) during CGM use spent in the target area 4.0-7.0 mmol/l, with glucose 7.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively, in pregnancy e. The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first three months after giving birth f. Infant growth and health at three months of age g. The prevalence of fetal overgrowth, defined as the offspring birth weight SD score >90th percentile h. The prevalence of miscarriage, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death i. Neonatal morbidity (neonatal hypoglycemia, jaundice, respiratory distress and duration of stay in neonatal intensive care unit), mode of delivery (vaginal, cesarean section, instrumental delivery) j. Maternal gestational weight gain and weight retention three months after delivery We also aim to explore: k. In women on insulin pump therapy, appropriate insulin pump settings (mainly carbohydrate ratio and sensitivity) in pregnancy and during lactation ;Timepoint(s) of evaluation of this end point: From inclusion in early pregnancy until three months after delivery

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Countries

Denmark

Contacts

Public ContactPrincipal investigator

Lene Ringholm

lene.ringholm.02@regionh.dk45No35451336No

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026