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Completed

NCT Number: NCT03770767

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Center for Pregnant Women with Diabetes, Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faster-acting Aspart insulin Fiasp

Drug

Randomization to treatment with insulin Fiasp

Other names: Insulin Fiasp

Control (insulin Novorapid)

Drug

Randomization to standard treatment with insulin Novorapid

Other names: First generation insulin analog

Primary outcomes

  1. Birth weight standard deviation score

    Time frame: At delivery

    Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender

Secondary outcomes

  1. 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

  2. Postprandial self-monitoring of plasma glucose (SMPG) levels

    Time frame: 9 months

    Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy

  3. Preprandial self-monitoring of plasma glucose (SMPG) levels

    Time frame: 9 months

    Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy

  4. 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.

  5. 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.

  6. 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

  7. Mild hypoglycaemia

    Time frame: 12 months

    The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.

  8. 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

  9. 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

  10. Fetal overgrowth

    Time frame: At birth

    The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile

  11. Infant weight

    Time frame: 3 months

    Infant weight during the first 3 months of life

  12. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2018
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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