<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/NCT04449692</url>
  </required_header>
  <id_info>
    <org_study_id>H-20013256</org_study_id>
    <secondary_id>2020-000551-12</secondary_id>
    <secondary_id>H-20013256</secondary_id>
    <nct_id>NCT04449692</nct_id>
  </id_info>
  <brief_title>Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes</brief_title>
  <official_title>Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steno Diabetes Center Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Steno Diabetes Center Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma,&#xD;
      Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia&#xD;
      in CSII- and MDI-treated people with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Near-normalization of blood glucose levels through intensive insulin therapy has shown to&#xD;
      reduce the risk of diabetes late complications, but the approach is associated with two major&#xD;
      side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral&#xD;
      carbohydrate consumption is generally effective, the approach can lead to excessive&#xD;
      carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that&#xD;
      subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia&#xD;
      in people with type 1 diabetes. However, the instability in aqueous solution of currently&#xD;
      available glucagon and the need for reconstitution with sterile water immediately prior to&#xD;
      administration has limited its clinical role outside emergency settings. Due to the stability&#xD;
      and ready-to-use formulation, dasiglucagon does not hold the limitations known for the&#xD;
      currently available glucagon preparations.&#xD;
&#xD;
      The aim of this randomized, partially single-blinded, three-arm cross-over study is to&#xD;
      compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g)&#xD;
      consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated&#xD;
      people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin&#xD;
      bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l.&#xD;
      When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be&#xD;
      administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">January 4, 2021</completion_date>
  <primary_completion_date type="Actual">January 4, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Partially single-blinded (oral carbohydrate administration will not be blinded)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between study visits in time (min) in hypoglycemia (plasma glucose &lt; 3.9 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incidence rate of hypoglycemia (plasma glucose &lt; 3.9 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose &lt; 3.0 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose &gt; 10 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (min) in hyperglycemia (plasma glucose &gt; 10 mmol/l) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (%) in hypoglycemia (plasma glucose &lt; 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in dose (units) of insulin bolus at study start (t = 0)</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention</measure>
    <time_frame>Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>80 µg s.c. dasiglucagon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l</description>
  </arm_group>
  <arm_group>
    <arm_group_label>120 µg s.c. dasiglucagon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15 g oral carbohydrate (dextrose tablets)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasiglucagon</intervention_name>
    <description>Abdominal s.c. administration</description>
    <arm_group_label>120 µg s.c. dasiglucagon</arm_group_label>
    <arm_group_label>80 µg s.c. dasiglucagon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carbohydrate (dextrose tablets)</intervention_name>
    <description>Oral administration</description>
    <arm_group_label>15 g oral carbohydrate (dextrose tablets)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-64 years&#xD;
&#xD;
          -  Duration of T1D ≥ 3 years&#xD;
&#xD;
          -  Use of CSII or MDI therapy for ≥ 6 months&#xD;
&#xD;
          -  Current use of Novorapid (change from another fast-acting insulin to Novorapid prior&#xD;
             to study initiation is allowed)&#xD;
&#xD;
          -  HbA1c ≤ 8.0%&#xD;
&#xD;
          -  Regular use of carbohydrate counting in the judgement of the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs&#xD;
             affecting glucose metabolism during the study period or within 30 days prior to study&#xD;
             start&#xD;
&#xD;
          -  History of allergy or intolerance to glucagon or glucagon-like products&#xD;
&#xD;
          -  Patients with pheochromocytoma&#xD;
&#xD;
          -  Clinically significant ECG abnormalities&#xD;
&#xD;
          -  Females who are pregnant, breast-feeding or intend to become pregnant or are not using&#xD;
             adequate contraceptive methods (sterilization, intrauterine device, contraceptive&#xD;
             pill, patch or injection)&#xD;
&#xD;
          -  Inability to understand the individual information and to give informed consent&#xD;
&#xD;
          -  Current participation in another clinical trial that, in the judgment of the principle&#xD;
             investigator, will compromise the results of the study or the safety of the subject&#xD;
&#xD;
          -  Other concomitant medical or psychological condition that, according to the&#xD;
             investigator's assessment, makes the individual unsuitable for study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Laugesen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD, PhD Candidate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Steno Diabetes Center Copenhagen</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Dasiglucagon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04449692
org study id: H-20013256
secondary id: 2020-000551-12
secondary id: H-20013256
nct id: NCT04449692
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma,
      Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia
      in CSII- and MDI-treated people with type 1 diabetes.
Near-normalization of blood glucose levels through intensive insulin therapy has shown to
      reduce the risk of diabetes late complications, but the approach is associated with two major
      side effects: hypoglycemia and weight gain. Although management of hypoglycemia through oral
      carbohydrate consumption is generally effective, the approach can lead to excessive
      carbohydrate intake and cause rebound hyperglycemia. It has previously been demonstrated that
      subcutaneous (s.c.) low-dose glucagon can be utilized to effectively treat mild hypoglycemia
      in people with type 1 diabetes. However, the instability in aqueous solution of currently
      available glucagon and the need for reconstitution with sterile water immediately prior to
      administration has limited its clinical role outside emergency settings. Due to the stability
      and ready-to-use formulation, dasiglucagon does not hold the limitations known for the
      currently available glucagon preparations.

      The aim of this randomized, partially single-blinded, three-arm cross-over study is to
      compare the efficacy of low-dose dasiglucagon (80 and 120 μg) to oral carbohydrate (15 g)
      consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated
      people with type 1 diabetes. On each study visit (separated by ≥ 3 days), an initial insulin
      bolus will be administered (at t = 0) aiming for a plasma glucose (PG) level of 3.0 mmol/l.
      When reaching 4.5 mmol/l, the intervention (s.c. dasiglucagon or oral carbohydrates) will be
      administered (t-intervention = 0), whereafter PG will me monitored for an additional 180 min.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Single-blinded, randomized (using blocks of 3/6 and stratification by treatment modality), three-arm crossover study
primary purpose: Treatment
masking: Single (Participant)
masking description: Partially single-blinded (oral carbohydrate administration will not be blinded)
measure: Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in dose (units) of insulin bolus at study start (t = 0)
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
measure: Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention
time frame: Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
arm group label: 80 µg s.c. dasiglucagon
arm group type: Experimental
description: 80 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l
arm group label: 120 µg s.c. dasiglucagon
arm group type: Experimental
description: 120 µg of dasiglucagon will be administered subcutaneously when plasma glucose levels reach 4.5 mmol/l
arm group label: 15 g oral carbohydrate (dextrose tablets)
arm group type: Active Comparator
description: 15 g of oral carbohydrate (dextrose tablets) will be administered when plasma glucose levels reach 4.5 mmol/l
intervention type: Drug
intervention name: Dasiglucagon
description: Abdominal s.c. administration
arm group label: 120 µg s.c. dasiglucagon
arm group label: 80 µg s.c. dasiglucagon
intervention type: Other
intervention name: Carbohydrate (dextrose tablets)
description: Oral administration
arm group label: 15 g oral carbohydrate (dextrose tablets)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Christian Laugesen, MD
role: Principal Investigator
affiliation: MD, PhD Candidate
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: No