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

Primary Purpose

Diabetes Mellitus, Pregnancy Complications

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Faster-acting Aspart insulin Fiasp
Control (insulin Novorapid)
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Pregnant Women with Diabetes, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention with insulin Fiasp

Control (insulin Novorapid)

Arm Description

Women randomized to insulin Fiasp

Women randomized to insulin NovoRapid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c levels
HbA1c levels in pregnancy, one and three months after delivery
Postprandial self-monitoring of plasma glucose (SMPG) levels
Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
Preprandial self-monitoring of plasma glucose (SMPG) levels
Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
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.
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.
Severe hypoglycemia
The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth
Mild hypoglycaemia
The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.
Maternal weight
Maternal weight in pregnancy and 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
Fetal overgrowth
The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile
Infant weight
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)
Neonatal morbidity

Full Information

First Posted
December 6, 2018
Last Updated
May 4, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03770767
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Pregnancy Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention with insulin Fiasp
Arm Type
Experimental
Arm Description
Women randomized to insulin Fiasp
Arm Title
Control (insulin Novorapid)
Arm Type
Active Comparator
Arm Description
Women randomized to insulin NovoRapid
Intervention Type
Drug
Intervention Name(s)
Faster-acting Aspart insulin Fiasp
Other Intervention Name(s)
Insulin Fiasp
Intervention Description
Randomization to treatment with insulin Fiasp
Intervention Type
Drug
Intervention Name(s)
Control (insulin Novorapid)
Other Intervention Name(s)
First generation insulin analog
Intervention Description
Randomization to standard treatment with insulin Novorapid
Primary Outcome Measure Information:
Title
Birth weight standard deviation score
Description
Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
HbA1c levels
Description
HbA1c levels in pregnancy, one and three months after delivery
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
Title
Postprandial self-monitoring of plasma glucose (SMPG) levels
Description
Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
Time Frame
9 months
Title
Preprandial self-monitoring of plasma glucose (SMPG) levels
Description
Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
Time Frame
9 months
Title
Insulin treatment and dose (IU) including insulin pump settings
Description
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.
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
Title
Continuous glucose monitoring data
Description
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.
Time Frame
9 months
Title
Severe hypoglycemia
Description
The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth
Time Frame
2 years
Title
Mild hypoglycaemia
Description
The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.
Time Frame
12 months
Title
Maternal weight
Description
Maternal weight in pregnancy and after delivery
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
Title
Pregnancy complications and outcomes
Description
The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death
Time Frame
9 months
Title
Fetal overgrowth
Description
The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile
Time Frame
At birth
Title
Infant weight
Description
Infant weight during the first 3 months of life
Time Frame
3 months
Title
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)
Description
Neonatal morbidity
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Ringholm
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Pregnant Women with Diabetes, Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Baseline data can be shared upon request.
Citations:
PubMed Identifier
34086494
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.
Results Reference
derived
PubMed Identifier
33837106
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.
Results Reference
derived

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

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