<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/NCT01720303</url>
  </required_header>
  <id_info>
    <org_study_id>AGEE-3020</org_study_id>
    <nct_id>NCT01720303</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes</brief_title>
  <official_title>A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy</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 trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug&#xD;
      (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately&#xD;
      controlled on the current OAD therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2002</start_date>
  <completion_date type="Actual">April 10, 2003</completion_date>
  <primary_completion_date type="Actual">April 10, 2003</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>Change in HbA1c</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in FBG (Fasting Blood Glucose)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Rep + NPH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Premixed insulin/NPH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>repaglinide</intervention_name>
    <description>2 mg (tablets) before each main meal</description>
    <arm_group_label>Rep + NPH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isophane human insulin</intervention_name>
    <description>Injection s.c. (under the skin) at bedtime</description>
    <arm_group_label>Rep + NPH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin</intervention_name>
    <description>Injection s.c. (under the skin) twice daily</description>
    <arm_group_label>Premixed insulin/NPH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HbA1c between 7.5 % and 13.0% (both inclusive)&#xD;
&#xD;
          -  Fasting C-peptide above or equal to 0.33 nmol/l&#xD;
&#xD;
          -  BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of treatment with insulin within the last 6 months&#xD;
&#xD;
          -  Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</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>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100101</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>February 17, 2017</last_update_submitted>
  <last_update_submitted_qc>February 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2017</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Repaglinide</mesh_term>
    <mesh_term>Isophane Insulin, Human</mesh_term>
    <mesh_term>Insulin, Isophane</mesh_term>
    <mesh_term>Isophane insulin, beef</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/NCT01720303
org study id: AGEE-3020
nct id: NCT01720303
lead sponsor: 
has dmc: No
This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug
      (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately
      controlled on the current OAD therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c
measure: Change in FBG (Fasting Blood Glucose)
measure: Change in body weight
arm group label: Rep + NPH
arm group type: Experimental
arm group label: Premixed insulin/NPH
arm group type: Active Comparator
intervention type: Drug
intervention name: repaglinide
description: 2 mg (tablets) before each main meal
arm group label: Rep + NPH
intervention type: Drug
intervention name: isophane human insulin
description: Injection s.c. (under the skin) at bedtime
arm group label: Rep + NPH
intervention type: Drug
intervention name: insulin
description: Injection s.c. (under the skin) twice daily
arm group label: Premixed insulin/NPH
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
country: China
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: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Repaglinide
mesh term: Isophane Insulin, Human
mesh term: Insulin, Isophane
mesh term: Isophane insulin, beef