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

Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770767
• Other study ID #: U1111
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2019
• Est. completion date: March 23, 2023

Study information

• Verified date: May 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Pregnant Women with Diabetes, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight standard deviation score	Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender	At delivery
Secondary	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
Secondary	Postprandial self-monitoring of plasma glucose (SMPG) levels	Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy	9 months
Secondary	Preprandial self-monitoring of plasma glucose (SMPG) levels	Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy	9 months
Secondary	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
Secondary	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
Secondary	Severe hypoglycemia	The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth	2 years
Secondary	Mild hypoglycaemia	The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.	12 months
Secondary	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
Secondary	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
Secondary	Fetal overgrowth	The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile	At birth
Secondary	Infant weight	Infant weight during the first 3 months of life	3 months
Secondary	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