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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

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Birth weight standard deviation score [ Time Frame: At delivery ]
Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • HbA1c levels [ Time Frame: 9 months ]
    HbA1c levels in pregnancy
  • Postprandial self-monitoring of plasma glucose (SMPG) levels [ Time Frame: 9 months ]
    Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
  • Preprandial self-monitoring of plasma glucose (SMPG) levels [ Time Frame: 9 months ]
    Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
  • 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
  • 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
  • Infant weight [ Time Frame: Three months ]
    Infant weight at one month and three months of age
  • Fetal overgrowth [ Time Frame: At birth ]
    The prevalence of fetal overgrowth, defined as the offspring birth weight SD score >90th percentile
  • 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
  • Neonatal morbidity [ Time Frame: At birth ]
    Neonatal morbidity
  • Maternal weight [ Time Frame: 12 months ]
    Maternal weight in pregnancy and after delivery
  • Insulin dose (IU) in insulin pumps [ Time Frame: 12 months ]
    In women on insulin pump therapy: appropriate insulin pump dosing (IU)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Pregnancy Complications
Intervention  ICMJE
  • Drug: Faster-acting Aspart insulin Fiasp
    Randomization to treatment with insulin Fiasp
    Other Name: Insulin Fiasp
  • Drug: Control (insulin Novorapid)
    Randomization to standard treatment with insulin Novorapid
    Other Name: First generation insulin analog
Study Arms  ICMJE
  • Experimental: Intervention with insulin Fiasp
    Women randomized to insulin Fiasp
    Intervention: Drug: Faster-acting Aspart insulin Fiasp
  • Active Comparator: Control (insulin Novorapid)
    Women randomized to insulin NovoRapid
    Intervention: Drug: Control (insulin Novorapid)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2019)
220
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
200
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lene Ringholm +45 3545 8671 lene.ringholm.02@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03770767
Other Study ID Numbers  ICMJE U1111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Baseline data can be shared upon request.
Responsible Party Lene Ringholm, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lene Ringholm Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP