<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/NCT03244241</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1177-2744</org_study_id>
    <nct_id>NCT03244241</nct_id>
  </id_info>
  <brief_title>Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study</brief_title>
  <official_title>Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merete Bechmann Christensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperglycemia during admission is associated with increased rate of complications and longer&#xD;
      hospital stays, thus insulin treatment is recommended for all diabetes patients with&#xD;
      hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control&#xD;
      with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but&#xD;
      increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin&#xD;
      therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently&#xD;
      than sliding scale insulin, with few episodes of hypoglycemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate and compare the efficacy and safety of basal-bolus&#xD;
      insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart&#xD;
      before meals versus standard therapy with sliding scale insulin in non-critical ill&#xD;
      hospitalized patients with type 2 diabetes.&#xD;
&#xD;
      The design of the trial is an open, randomized controlled trial with two parallel arms&#xD;
      (treatment arm and control arm). Randomization is 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2018</primary_completion_date>
  <phase>Phase 4</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>Difference in mean daily plasma glucose between the two groups</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Based on bedside PG measures and on CGM data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in glycemic range</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Based on bedside PG measures and on CGM data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in hyperglycemic range</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Based on bedside PG measures and on CGM data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Mean duration of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in insulin dose between groups</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Calculated as mean insulin dose during admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital acquired infections during admission</measure>
    <time_frame>Duration of hospital stay, an expected average of 8 days</time_frame>
    <description>Data from hospital record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of post-discharge infections or re-admissions 1 month after discharge</measure>
    <time_frame>1 month</time_frame>
    <description>Data collected on follow-up 1 month after discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basal-bolus insulin regime with Insulin Degludec and insulin aspart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment according to hospital guidelines with sliding scale insulin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Degludec 100 UNT/ML [Tresiba]</intervention_name>
    <description>Basal-bolus insulin regime</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of type 2 diabetes for at least 6 months&#xD;
&#xD;
          -  Age 18 - 90 years&#xD;
&#xD;
          -  Pre-meal plasma glucose in the range 10 - 22,2 mmol/L prior to inclusion&#xD;
&#xD;
          -  Expected hospital stay longer than 4 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hyperglycemia without known history of type 2 diabetes&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Severely impaired renal function (eGFR ≤ 30 mL/min/1,73 m2)&#xD;
&#xD;
          -  Severe hepatic disease&#xD;
&#xD;
          -  Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or&#xD;
             diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6&#xD;
             months&#xD;
&#xD;
          -  Pregnant or lactating women or fertile female patients not using chemical, hormonal or&#xD;
             mechanical contraceptives or not in menopause (i.e. must not have had regular&#xD;
             menstrual bleeding for at least one year)&#xD;
&#xD;
          -  Planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12&#xD;
             hours&#xD;
&#xD;
          -  Treatment at admission or planned treatment during hospital stay with parenteral&#xD;
             nutrition or enteral nutrition (i.e. gastroenteric tube feeding)&#xD;
&#xD;
          -  Treatment at admission or planned treatment during hospital stay with high dose&#xD;
             glucocorticoids (&gt;40 mg)&#xD;
&#xD;
          -  History or presence of malignancy (except basal skin cancer) unless a disease-free&#xD;
             period exceeding five years&#xD;
&#xD;
          -  Presence of alcohol or drug abuse&#xD;
&#xD;
          -  Inability to understand the written information or incapability to provide informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten B Norgaard, DMSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hvidovre University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Merete B Christensen, MD</last_name>
    <phone>23811264</phone>
    <email>merete.bechmann.christensen.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kirsten Norgaard, DMSC</last_name>
    <email>kirsten.noergaard@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hvidovre University Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Merete B. Christensen, MD</last_name>
      <phone>+4538623389</phone>
      <email>merete.bechmann.christensen.01@regionh.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Merete Bechmann Christensen</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes, inpatient diabetes management, basal-bolus insulin</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 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03244241
org study id: U1111-1177-2744
nct id: NCT03244241
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Hyperglycemia during admission is associated with increased rate of complications and longer
      hospital stays, thus insulin treatment is recommended for all diabetes patients with
      hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control
      with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but
      increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin
      therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently
      than sliding scale insulin, with few episodes of hypoglycemia.
The aim of this study is to investigate and compare the efficacy and safety of basal-bolus
      insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart
      before meals versus standard therapy with sliding scale insulin in non-critical ill
      hospitalized patients with type 2 diabetes.

      The design of the trial is an open, randomized controlled trial with two parallel arms
      (treatment arm and control arm). Randomization is 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in mean daily plasma glucose between the two groups
time frame: Duration of hospital stay, an expected average of 8 days
description: Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.
measure: Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
time frame: Duration of hospital stay, an expected average of 8 days
description: Based on bedside PG measures and on CGM data
measure: Time spent in glycemic range
time frame: Duration of hospital stay, an expected average of 8 days
description: Based on bedside PG measures and on CGM data
measure: Time spent in hyperglycemic range
time frame: Duration of hospital stay, an expected average of 8 days
description: Based on bedside PG measures and on CGM data
measure: Length of hospital stay
time frame: Duration of hospital stay, an expected average of 8 days
description: Mean duration of hospital stay
measure: Difference in insulin dose between groups
time frame: Duration of hospital stay, an expected average of 8 days
description: Calculated as mean insulin dose during admission
measure: Number of hospital acquired infections during admission
time frame: Duration of hospital stay, an expected average of 8 days
description: Data from hospital record
measure: Number of post-discharge infections or re-admissions 1 month after discharge
time frame: 1 month
description: Data collected on follow-up 1 month after discharge
arm group label: Intervention
arm group type: Active Comparator
description: Basal-bolus insulin regime with Insulin Degludec and insulin aspart
arm group label: Standard
arm group type: No Intervention
description: Standard treatment according to hospital guidelines with sliding scale insulin
intervention type: Drug
intervention name: Insulin Degludec 100 UNT/ML [Tresiba]
description: Basal-bolus insulin regime
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kirsten B Norgaard, DMSC
role: Principal Investigator
affiliation: Hvidovre University Hospital
last name: Merete B Christensen, MD
phone: 23811264
email: merete.bechmann.christensen.01@regionh.dk
last name: Kirsten Norgaard, DMSC
email: kirsten.noergaard@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Merete Bechmann Christensen
investigator title: Principle investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
sharing ipd: Undecided