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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 23, 2023

Interventions

  • Drug: Faster-acting Aspart insulin Fiasp
    • Randomization to treatment with insulin Fiasp
  • Drug: Control (insulin Novorapid)
    • Randomization to standard treatment with insulin Novorapid

Arms, Groups and Cohorts

  • Experimental: Intervention with insulin Fiasp
    • Women randomized to insulin Fiasp
  • Active Comparator: Control (insulin Novorapid)
    • Women randomized to insulin NovoRapid

Clinical Trial Outcome Measures

Primary Measures

  • Birth weight standard deviation score
    • Time Frame: At delivery
    • Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender

Secondary Measures

  • HbA1c levels
    • Time Frame: 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
    • HbA1c levels in pregnancy, one and three months after delivery
  • Postprandial self-monitoring of plasma glucose (SMPG) levels
    • Time Frame: 9 months
    • Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
  • Preprandial self-monitoring of plasma glucose (SMPG) levels
    • Time Frame: 9 months
    • Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
  • Insulin treatment and dose (IU) including insulin pump settings
    • Time Frame: 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
    • 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.
  • Continuous glucose monitoring data
    • Time Frame: 9 months
    • 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.
  • Severe hypoglycemia
    • Time Frame: 2 years
    • The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth
  • Mild hypoglycaemia
    • Time Frame: 12 months
    • The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.
  • Maternal weight
    • Time Frame: 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
    • Maternal weight in pregnancy and after delivery
  • Pregnancy complications and outcomes
    • Time Frame: 9 months
    • The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death
  • Fetal overgrowth
    • Time Frame: At birth
    • The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile
  • Infant weight
    • Time Frame: 3 months
    • Infant weight during the first 3 months of life
  • 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)
    • Time Frame: 3 months
    • Neonatal morbidity

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lene Ringholm, Chief physician – Rigshospitalet, Denmark
  • Overall Official(s)
    • Lene Ringholm, Principal Investigator, Rigshospitalet, Denmark

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