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Diabetes MellitusPhase 3NCT03770767

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

A Phase 3 study testing Faster-acting Aspart insulin Fiasp in people with Diabetes Mellitus and Pregnancy Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Diabetes Mellitus, Pregnancy Complications
What is being tested?
Faster-acting Aspart insulin Fiasp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteDenmark
Study dates
11 Nov 2019to 23 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Pregnant Women with Diabetes, Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

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

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.

Being tested
Faster-acting Aspart insulin Fiasp, Control (insulin Novorapid)
Medical subject headings
Diabetes Mellitus, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Faster-acting Aspart insulin FiaspDrug

    Also called Insulin Fiasp

    Randomization to treatment with insulin Fiasp

  • Control (insulin Novorapid)Drug

    Also called First generation insulin analog

    Randomization to standard treatment with insulin Novorapid

Study groups in NCT03770767
Study groupRoleWhat they receive
Intervention with insulin FiaspExperimentalWomen randomized to insulin Fiasp
Receives: Drug: Faster-acting Aspart insulin Fiasp
Control (insulin Novorapid)Active comparatorWomen randomized to insulin NovoRapid
Receives: Drug: Control (insulin Novorapid)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Birth weight standard deviation score

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

    Measured: At delivery

Secondary outcomes (12)

  1. HbA1c levels

    HbA1c levels in pregnancy, one and three months after delivery

    Measured: 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

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

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

    Measured: 9 months

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

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

    Measured: 9 months

  4. 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.

    Measured: 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

  5. 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.

    Measured: 9 months

  6. Severe hypoglycemia

    The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth

    Measured: 2 years

  7. Mild hypoglycaemia

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

    Measured: 12 months

  8. Maternal weight

    Maternal weight in pregnancy and after delivery

    Measured: 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

  9. 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

    Measured: 9 months

  10. Fetal overgrowth

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

    Measured: At birth

  11. Infant weight

    Infant weight during the first 3 months of life

    Measured: 3 months

  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)

    Neonatal morbidity

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2018
  2. Study start11 Nov 2019
  3. Primary completion23 Mar 2023
  4. Study completion23 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03770767
Sponsor's protocol ID
U1111
Status last verified
May 2023
First submitted
6 Dec 2018
Last updated
6 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Baseline data can be shared upon request.

Publications

  • Norgaard SK, Soholm JC, Mathiesen ER, Norgaard K, Clausen TD, Holmager P, Do NC, Damm P, Ringholm L. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Nov;11(11):811-821. doi: 10.1016/S2213-8587(23)00236-X. Epub 2023 Oct 4.

    PubMed 37804858

  • 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.

    PubMed 34086494

  • 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.

    PubMed 33837106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faster-acting Aspart insulin Fiasp in people with Diabetes Mellitus and Pregnancy Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Birth weight standard deviation score (time frame: At delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03770767, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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