Clinical trial NCT03770767: Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Pregnancy Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Birth weight standard deviation score
timeFrame: At delivery
Secondary outcomes:
measure: HbA1c levels
timeFrame: 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
measure: Postprandial self-monitoring of plasma glucose (SMPG) levels
timeFrame: 9 months
measure: Preprandial self-monitoring of plasma glucose (SMPG) levels
timeFrame: 9 months
measure: Insulin treatment and dose (IU) including insulin pump settings
timeFrame: 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
measure: Continuous glucose monitoring data
timeFrame: 9 months
measure: Severe hypoglycemia
timeFrame: 2 years
measure: Mild hypoglycaemia
timeFrame: 12 months
measure: Maternal weight
timeFrame: 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
measure: Pregnancy complications and outcomes
timeFrame: 9 months
measure: Fetal overgrowth
timeFrame: At birth
measure: Infant weight
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Pregnant Women with Diabetes, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Ringholm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norgaard SK, Mathiesen ER, Norgaard K, Ringholm L. Comparison of Glycemic Metrics Measured Simultaneously by Intermittently Scanned Continuous Glucose Monitoring and Real-Time Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Oct;23(10):665-672. doi: 10.1089/dia.2021.0109. Epub 2021 Jun 25.
citation: Norgaard SK, Mathiesen ER, Norgaard K, Clausen TD, Damm P, Ringholm L. CopenFast trial: 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. BMJ Open. 2021 Apr 9;11(4):e045650. doi: 10.1136/bmjopen-2020-045650.