<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/NCT02219750</url>
  </required_header>
  <id_info>
    <org_study_id>13MMHISO71,13MMHISO72</org_study_id>
    <nct_id>NCT02219750</nct_id>
  </id_info>
  <brief_title>Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients</brief_title>
  <acronym>COMPAR</acronym>
  <official_title>Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mackay Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of efficacy and safety of different insulin regimens between basal bolus and&#xD;
      premixed insulin in poorly controlled type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in&#xD;
      approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay&#xD;
      Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a&#xD;
      1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The&#xD;
      effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24&#xD;
      weeks after initiation of study prescription. The safety will be followed during the 24-week&#xD;
      study period. All study procedure will be conducted after obtaining informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>24week duration</time_frame>
    <description>To compare the change in HbA1c from baseline to endpoint for each groups at Week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>achieving goal percentage</measure>
    <time_frame>24weeks duration</time_frame>
    <description>To compare the proportion of patients achieving HbA1c &lt; 7% at Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma glucose</measure>
    <time_frame>24 week duration</time_frame>
    <description>To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight change</measure>
    <time_frame>24 weeks duration</time_frame>
    <description>To compare the change in body weight at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of hypoglcyemia</measure>
    <time_frame>24 weeks duration</time_frame>
    <description>To evaluate the incidence of self-reported hypoglycemia episodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total insulin dose</measure>
    <time_frame>24 weeks duration</time_frame>
    <description>To estimate total insulin dose.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>C peptide</measure>
    <time_frame>24weeks</time_frame>
    <description>to compare serum C peptide between baseline and end of trial</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Preprandial premix therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>switch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal-plus insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>switch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>switch twice-daily insulin</intervention_name>
    <description>compare two different insuiln regimen in basal insuln base and premixed insulin.&#xD;
NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin</description>
    <arm_group_label>Basal-plus insulin</arm_group_label>
    <arm_group_label>Preprandial premix therapy</arm_group_label>
    <other_name>NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with type 2 diabetes.(World Health Organization classification) &gt; 20&#xD;
             years of age.&#xD;
&#xD;
          -  Patients who have received stable doses of any OADs for at least 12 weeks prior to the&#xD;
             screening visit.&#xD;
&#xD;
          -  treatment with basal insulin plus OADs &gt;3 months with suboptimal glycemic control&#xD;
             (HbA1c &gt;7%)&#xD;
&#xD;
          -  FBG &lt;130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose &gt;0.7U/kg or had history of&#xD;
             nocturnal hypoglycemia&#xD;
&#xD;
          -  Patients who are willing and able to cooperate with study and give signed informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type 1 diabetes.&#xD;
&#xD;
          -  History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.&#xD;
&#xD;
          -  Patients who had received any investigational insulin for more than 3 months or who&#xD;
             have received investigational insulin treatment within 4 weeks prior to screening&#xD;
             visit.&#xD;
&#xD;
          -  Patients hypersensitive with insulin analog or its excipients.&#xD;
&#xD;
          -  Patients who are currently pregnant/lactating, or who are preparing for pregnancy or&#xD;
             lactation.&#xD;
&#xD;
          -  Renal dialysis patients, patients with severe liver disease or congestive heart&#xD;
             failure&#xD;
&#xD;
          -  BMI &gt;40kg/m2&#xD;
&#xD;
          -  Excessive insulin resistance (total daily insulin dose&gt;2.0unit/kg)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sung-Chen Liu, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mackay Memerial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sung-Chen Liu</investigator_full_name>
    <investigator_title>Mackay Memorial Hospital</investigator_title>
  </responsible_party>
  <keyword>premix insuiln, basal-plus insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin aspart, insulin aspart protamine drug combination 30:70</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/NCT02219750
org study id: 13MMHISO71,13MMHISO72
nct id: NCT02219750
lead sponsor: 
has dmc: Yes
Comparison of efficacy and safety of different insulin regimens between basal bolus and
      premixed insulin in poorly controlled type 2 diabetes
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in
      approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay
      Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a
      1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The
      effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24
      weeks after initiation of study prescription. The safety will be followed during the 24-week
      study period. All study procedure will be conducted after obtaining informed consent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: HbA1c
time frame: 24week duration
description: To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
measure: achieving goal percentage
time frame: 24weeks duration
description: To compare the proportion of patients achieving HbA1c < 7% at Week 24.
measure: plasma glucose
time frame: 24 week duration
description: To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.
measure: weight change
time frame: 24 weeks duration
description: To compare the change in body weight at each visit.
measure: incidence of hypoglcyemia
time frame: 24 weeks duration
description: To evaluate the incidence of self-reported hypoglycemia episodes.
measure: total insulin dose
time frame: 24 weeks duration
description: To estimate total insulin dose.
measure: C peptide
time frame: 24weeks
description: to compare serum C peptide between baseline and end of trial
arm group label: Preprandial premix therapy
arm group type: Active Comparator
description: switch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone
arm group label: Basal-plus insulin
arm group type: Active Comparator
description: switch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose.
intervention type: Drug
intervention name: switch twice-daily insulin
description: compare two different insuiln regimen in basal insuln base and premixed insulin.
NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin
arm group label: Basal-plus insulin
arm group label: Preprandial premix therapy
other name: NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sung-Chen Liu, master
role: Principal Investigator
affiliation: Mackay Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Mackay Memorial Hospital
investigator full name: Sung-Chen Liu
investigator title: Mackay Memorial Hospital
mesh term: Diabetes Mellitus
mesh term: Insulin aspart, insulin aspart protamine drug combination 30:70