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

Study Overview
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Brief Summary
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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.

Official Title
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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. The Copen-fast Trial

Conditions
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Diabetes Mellitus, Pregnancy Complications

Intervention / Treatment
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* Drug: Faster-acting Aspart insulin Fiasp
* Drug: Control (insulin Novorapid)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with insulin Fiasp<br>Women randomized to insulin Fiasp | Drug: Faster-acting Aspart insulin Fiasp<br>* Randomization to treatment with insulin Fiasp<br>* Other names: Insulin Fiasp;|
| Active Comparator: Control (insulin Novorapid)<br>Women randomized to insulin NovoRapid | Drug: Control (insulin Novorapid)<br>* Randomization to standard treatment with insulin Novorapid<br>* Other names: First generation insulin analog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight standard deviation score | Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | HbA1c levels in pregnancy, one and three months after delivery | At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery | 
| Postprandial self-monitoring of plasma glucose (SMPG) levels | Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy | 9 months | 
| Preprandial self-monitoring of plasma glucose (SMPG) levels | Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy | 9 months | 
| Insulin treatment and dose (IU) including insulin pump settings | Type of insulin, dose (IU) during pregnancy, around delivery and until 3 months after delivery. In women on insulin pump therapy: appropriate insulin pump dosing (IU) during pregnancy, around delivery and until 3 months after delivery. | At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery | 
| Continuous glucose monitoring data | The amount of time during CGM use spent in the target range 3.5-7.8 mmol/l, with glucose <3.5 mmol/L and glucose >7.8 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively, in pregnancy and around delivery (in the morning for induction of labour or planned caesarean section). • The percentage of time during the first one-week period after delivery spent in the target range 3.9-10.0 mmol/L, with glucose <3.9 mmol/L and glucose >10.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively. | 9 months | 
| Severe hypoglycemia | The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth | 2 years | 
| Mild hypoglycaemia | The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth. | 12 months | 
| Maternal weight | Maternal weight in pregnancy and after delivery | At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery | 
| Pregnancy complications and outcomes | The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death | 9 months | 
| Fetal overgrowth | The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile | At birth | 
| Infant weight | Infant weight during the first 3 months of life | 3 months | 
| Neonatal morbidity (neonatal hypoglycaemia, jaundice, respiratory distress and duration of stay in neonatal intensive care unit) and infant morbidity evaluated as hospitalization during the first 3 months of life (after discharge in the neonatal period) | Neonatal morbidity | 3 months |