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

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ClinicalTrials.gov Identifier: NCT03770767
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lene Ringholm, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Pregnancy Complications Drug: Faster-acting Aspart insulin Fiasp Drug: Control (insulin Novorapid) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention with insulin Fiasp
Women randomized to insulin Fiasp
Drug: Faster-acting Aspart insulin Fiasp
Randomization to treatment with insulin Fiasp
Other Name: Insulin Fiasp

Active Comparator: Control (insulin Novorapid)
Women randomized to insulin NovoRapid
Drug: Control (insulin Novorapid)
Randomization to standard treatment with insulin Novorapid
Other Name: First generation insulin analog




Primary Outcome Measures :
  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 Outcome Measures :
  1. HbA1c levels [ Time Frame: 9 months ]
    HbA1c levels in pregnancy

  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. 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

  5. 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

  6. Infant weight [ Time Frame: Three months ]
    Infant weight at one month and three months of age

  7. Fetal overgrowth [ Time Frame: At birth ]
    The prevalence of fetal overgrowth, defined as the offspring birth weight SD score >90th percentile

  8. Pregnancy complications and outcomes [ Time Frame: 9 months ]
    The prevalence of miscarriage, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death

  9. Neonatal morbidity [ Time Frame: At birth ]
    Neonatal morbidity

  10. Maternal weight [ Time Frame: 12 months ]
    Maternal weight in pregnancy and after delivery

  11. Insulin dose (IU) in insulin pumps [ Time Frame: 12 months ]
    In women on insulin pump therapy: appropriate insulin pump dosing (IU)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women, age ≥ 18 years
  • Duration of type 1 diabetes ≥ 12 months or type 2 diabetes (any duration)
  • Pregnant with an intrauterine singleton living fetus (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan

Exclusion Criteria:

  • A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
  • No proficiency in Danish to understand oral and written information
  • Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or NPH insulin and not willing to continue routine treatment modality
  • Women with type 2 diabetes who before pregnancy were either treated with diet, oral antidiabetic therapy or pre-mixed insulin who are not willing to change to trial medication according to randomisation or to an appropriate long-acting insulin analog as insulin detemir, insulin degludec, insulin glargine, insulin abasaglar or insulin toujeo (as part of routine MDI therapy in type 2 diabetes), as indicated.
  • Women with type 1 diabetes using an insulin pump that is not compatible with trial medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770767


Contacts
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Contact: Lene Ringholm +45 3545 8671 lene.ringholm.02@regionh.dk

Locations
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Denmark
Center for Pregnant Women with Diabetes, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lene Ringholm         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Lene Ringholm Rigshospitalet, Denmark

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Responsible Party: Lene Ringholm, Chief physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03770767     History of Changes
Other Study ID Numbers: U1111
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Baseline data can be shared upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs