<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770767</url>
  </required_header>
  <id_info>
    <org_study_id>U1111</org_study_id>
    <nct_id>NCT03770767</nct_id>
  </id_info>
  <brief_title>Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised controlled, open-label trial in an unselected cohort of pregnant women with type&#xD;
      1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and&#xD;
      lactation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">March 23, 2023</completion_date>
  <primary_completion_date type="Actual">March 23, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Birth weight standard deviation score</measure>
    <time_frame>At delivery</time_frame>
    <description>Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c levels</measure>
    <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</time_frame>
    <description>HbA1c levels in pregnancy, one and three months after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial self-monitoring of plasma glucose (SMPG) levels</measure>
    <time_frame>9 months</time_frame>
    <description>Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preprandial self-monitoring of plasma glucose (SMPG) levels</measure>
    <time_frame>9 months</time_frame>
    <description>Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin treatment and dose (IU) including insulin pump settings</measure>
    <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</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous glucose monitoring data</measure>
    <time_frame>9 months</time_frame>
    <description>The amount of time during CGM use spent in the target range 3.5-7.8 mmol/l, with glucose &lt;3.5 mmol/L and glucose &gt;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 &lt;3.9 mmol/L and glucose &gt;10.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe hypoglycemia</measure>
    <time_frame>2 years</time_frame>
    <description>The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mild hypoglycaemia</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal weight</measure>
    <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</time_frame>
    <description>Maternal weight in pregnancy and after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications and outcomes</measure>
    <time_frame>9 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal overgrowth</measure>
    <time_frame>At birth</time_frame>
    <description>The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or &gt;90th percentile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight</measure>
    <time_frame>3 months</time_frame>
    <description>Infant weight during the first 3 months of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <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)</measure>
    <time_frame>3 months</time_frame>
    <description>Neonatal morbidity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Intervention with insulin Fiasp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women randomized to insulin Fiasp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (insulin Novorapid)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women randomized to insulin NovoRapid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faster-acting Aspart insulin Fiasp</intervention_name>
    <description>Randomization to treatment with insulin Fiasp</description>
    <arm_group_label>Intervention with insulin Fiasp</arm_group_label>
    <other_name>Insulin Fiasp</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control (insulin Novorapid)</intervention_name>
    <description>Randomization to standard treatment with insulin Novorapid</description>
    <arm_group_label>Control (insulin Novorapid)</arm_group_label>
    <other_name>First generation insulin analog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Women, age ≥ 18 years&#xD;
&#xD;
          -  Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months&#xD;
&#xD;
          -  Type 2 diabetes (any duration)&#xD;
&#xD;
          -  Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan&#xD;
             between 8+0 and 13+6 gestational weeks&#xD;
&#xD;
          -  Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin&#xD;
             glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and&#xD;
             willing to continue routine treatment modality&#xD;
&#xD;
          -  Women with type 1 diabetes using an insulin pump compatible with trial products&#xD;
&#xD;
          -  Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed&#xD;
             insulin before pregnancy and willing to change to trial medication according to&#xD;
             randomization or to an appropriate long-acting insulin analogue, as indicated&#xD;
&#xD;
          -  Proficiency in Danish to understand oral and written information&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        • Severe mental or psychiatric barriers or concurrent disease on the decision of the&#xD;
        principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lene Ringholm</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Pregnant Women with Diabetes, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Lene Ringholm</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Baseline data can be shared upon request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770767
org study id: U1111
nct id: NCT03770767
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Birth weight standard deviation score
time frame: At delivery
description: Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender
measure: HbA1c levels
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
description: HbA1c levels in pregnancy, one and three months after delivery
measure: Postprandial self-monitoring of plasma glucose (SMPG) levels
time frame: 9 months
description: Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
measure: Preprandial self-monitoring of plasma glucose (SMPG) levels
time frame: 9 months
description: Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
measure: Insulin treatment and dose (IU) including insulin pump settings
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
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.
measure: Continuous glucose monitoring data
time frame: 9 months
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.
measure: Severe hypoglycemia
time frame: 2 years
description: The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth
measure: Mild hypoglycaemia
time frame: 12 months
description: The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.
measure: Maternal weight
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
description: Maternal weight in pregnancy and after delivery
measure: Pregnancy complications and outcomes
time frame: 9 months
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
measure: Fetal overgrowth
time frame: At birth
description: The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile
measure: Infant weight
time frame: 3 months
description: Infant weight during the first 3 months of life
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)
time frame: 3 months
description: Neonatal morbidity
arm group label: Intervention with insulin Fiasp
arm group type: Experimental
description: Women randomized to insulin Fiasp
arm group label: Control (insulin Novorapid)
arm group type: Active Comparator
description: Women randomized to insulin NovoRapid
intervention type: Drug
intervention name: Faster-acting Aspart insulin Fiasp
description: Randomization to treatment with insulin Fiasp
arm group label: Intervention with insulin Fiasp
other name: Insulin Fiasp
intervention type: Drug
intervention name: Control (insulin Novorapid)
description: Randomization to standard treatment with insulin Novorapid
arm group label: Control (insulin Novorapid)
other name: First generation insulin analog
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lene Ringholm
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Lene Ringholm
investigator title: Chief physician
mesh term: Pregnancy Complications
mesh term: Diabetes Mellitus
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Aspart
sharing ipd: No
ipd description: Baseline data can be shared upon request.