<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/NCT02198846</url>
  </required_header>
  <id_info>
    <org_study_id>KU_PUMP1</org_study_id>
    <nct_id>NCT02198846</nct_id>
  </id_info>
  <brief_title>A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes</brief_title>
  <official_title>A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type&#xD;
      2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents.&#xD;
      Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does&#xD;
      not only have efficacy in glucose control but also restore beta cell failure.&#xD;
&#xD;
      The investigators plan to compare the efficacy/safety and beta cell function between insulin&#xD;
      pump treatment and the intensification of conventional treatment in patients with&#xD;
      uncontrolled type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</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>change of HbA1c</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of body weight</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of hypoglycemia</measure>
    <time_frame>24 weeks</time_frame>
    <description>severe hypoglycemia : glucose &lt;40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of beta cell function</measure>
    <time_frame>24 weeks</time_frame>
    <description>insulin secretion-sensitivity index-2&#xD;
= insulinogenic index x Matsuda index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients who reach target goal of HbA1c (&lt;7.0%)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Insulin pump</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>insulin pump</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intensification of conventional treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>insulin pump</intervention_name>
    <description>stop any antihyperglycemic medication and convert to insulin pump</description>
    <arm_group_label>Insulin pump</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>conventional treatment</intervention_name>
    <description>intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)</description>
    <arm_group_label>conventional treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  age: 18 ~ 85 yrs&#xD;
&#xD;
          -  HbA1c: &gt; 7.5%&#xD;
&#xD;
          -  no change of anti-diabetic medication within 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic corticosteroid administered within previous 6 months&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe liver or renal disease, heart failure&#xD;
&#xD;
          -  History of cancer within 5 years&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Anti-obesity drugs or slimming products within previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soo Bong Choi, MD.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Soo Bong Choi, MD.PhD</last_name>
    <phone>+82-10-4949-9504</phone>
    <email>mellitus@empal.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Konkuk University Chungju Hospital</name>
      <address>
        <city>Chungju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Soo Bong Choi, MD.PhD</last_name>
      <phone>+82-10-4949-9504</phone>
      <email>mellitus@empal.com</email>
    </contact>
    <investigator>
      <last_name>Soo Bong Choi, MD.PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Soo Bong Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_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/NCT02198846
org study id: KU_PUMP1
nct id: NCT02198846
lead sponsor: 
has dmc: No
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type
      2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents.
      Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does
      not only have efficacy in glucose control but also restore beta cell failure.

      The investigators plan to compare the efficacy/safety and beta cell function between insulin
      pump treatment and the intensification of conventional treatment in patients with
      uncontrolled type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of HbA1c
time frame: 24 weeks
measure: changes of body weight
time frame: 24 weeks
measure: frequency of hypoglycemia
time frame: 24 weeks
description: severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl
measure: change of beta cell function
time frame: 24 weeks
description: insulin secretion-sensitivity index-2
= insulinogenic index x Matsuda index
measure: Percent of patients who reach target goal of HbA1c (<7.0%)
time frame: 24 weeks
arm group label: Insulin pump
arm group type: Experimental
description: insulin pump
arm group label: conventional treatment
arm group type: Active Comparator
description: intensification of conventional treatment
intervention type: Device
intervention name: insulin pump
description: stop any antihyperglycemic medication and convert to insulin pump
arm group label: Insulin pump
intervention type: Drug
intervention name: conventional treatment
description: intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)
arm group label: conventional treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Soo Bong Choi, MD.PhD
role: Principal Investigator
affiliation: Konkuk University
last name: Soo Bong Choi, MD.PhD
phone: +82-10-4949-9504
email: mellitus@empal.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Soo Bong Choi
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin