<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/NCT02230631</url>
  </required_header>
  <id_info>
    <org_study_id>INS-4142</org_study_id>
    <secondary_id>U1111-1147-4179</secondary_id>
    <nct_id>NCT02230631</nct_id>
  </id_info>
  <brief_title>A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes</brief_title>
  <official_title>A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This survey is conducted in South America. The aim of this survey is to investigate&#xD;
      hypoglycaemia among Insulin-treated patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients experiencing at least 1 hypoglycaemic event</measure>
    <time_frame>During 4 weeks from baseline visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycaemic events requiring hospital admission</measure>
    <time_frame>In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe hypoglycaemic events</measure>
    <time_frame>In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-severe hypoglycaemic events</measure>
    <time_frame>In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal hypoglycaemic events</measure>
    <time_frame>In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documented symptomatic hypoglycaemic events</measure>
    <time_frame>In the 4 weeks following the baseline visit (Patient Diary)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms</measure>
    <time_frame>In the 4 weeks following the baseline visit (Patient Diary)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All hypoglycaemic events (any type)</measure>
    <time_frame>In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the reported incidence rates of hypoglycaemia</measure>
    <time_frame>In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">704</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Part 1 (retrospective cross-sectional evaluation)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 (prospective observational evaluation)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment given</intervention_name>
    <description>Two different questionnaires will be applied to patients during a regular clinical visit.</description>
    <arm_group_label>Part 1 (retrospective cross-sectional evaluation)</arm_group_label>
    <arm_group_label>Part 2 (prospective observational evaluation)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty-five sites will be selected, distributed in different regions of the country, in&#xD;
        order to be representative of the Brazilian population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any study-related activities&#xD;
&#xD;
          -  The following patients will be considered eligible for inclusion in the study:&#xD;
             Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus)&#xD;
             treated with insulin for more than 12 months and patients at least 18 years of age at&#xD;
             the time of the survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation&#xD;
&#xD;
          -  Illiterate patients and patients otherwise unable to complete a written survey&#xD;
&#xD;
          -  Non-ambulatory patients&#xD;
&#xD;
          -  Simultaneous participation in any other clinical study with an investigational product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Säo Paulo</city>
        <zip>05001-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Hypoglycemia</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230631
org study id: INS-4142
secondary id: U1111-1147-4179
nct id: NCT02230631
lead sponsor: 
has dmc: No
This survey is conducted in South America. The aim of this survey is to investigate
      hypoglycaemia among Insulin-treated patients with diabetes.
observational model: Cohort
time perspective: Prospective
measure: The percentage of patients experiencing at least 1 hypoglycaemic event
time frame: During 4 weeks from baseline visit
measure: Hypoglycaemic events requiring hospital admission
time frame: In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Severe hypoglycaemic events
time frame: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Non-severe hypoglycaemic events
time frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Nocturnal hypoglycaemic events
time frame: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
measure: Documented symptomatic hypoglycaemic events
time frame: In the 4 weeks following the baseline visit (Patient Diary)
measure: Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms
time frame: In the 4 weeks following the baseline visit (Patient Diary)
measure: All hypoglycaemic events (any type)
time frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Difference in the reported incidence rates of hypoglycaemia
time frame: In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
arm group label: Part 1 (retrospective cross-sectional evaluation)
arm group label: Part 2 (prospective observational evaluation)
intervention type: Other
intervention name: No treatment given
description: Two different questionnaires will be applied to patients during a regular clinical visit.
arm group label: Part 1 (retrospective cross-sectional evaluation)
arm group label: Part 2 (prospective observational evaluation)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Brazil
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Hypoglycemia
mesh term: Diabetes Mellitus, Type 1