<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/NCT01698931</url>
  </required_header>
  <id_info>
    <org_study_id>AGEE-1259</org_study_id>
    <nct_id>NCT01698931</nct_id>
  </id_info>
  <brief_title>Efficacy of Repaglinide in Subjects With Type 2 Diabetes</brief_title>
  <official_title>Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial</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 Europe. The aim of this trial is to compare the efficacy of&#xD;
      repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2002</start_date>
  <completion_date type="Actual">March 6, 2003</completion_date>
  <primary_completion_date type="Actual">March 6, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Basal hepatic glucose production</measure>
    <time_frame>Day 0; day 44</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycaemic episodes</measure>
    <time_frame>Day 0; day 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Day 0; day 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Day 0; day 44</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment period 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment period 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>repaglinide</intervention_name>
    <description>1 mg before each main meal on three separate dosing visits separated by a wash-out period</description>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_label>Treatment period 2</arm_group_label>
    <arm_group_label>Treatment period 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glyburide</intervention_name>
    <description>5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period</description>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_label>Treatment period 2</arm_group_label>
    <arm_group_label>Treatment period 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Before each main meal on three separate dosing visits separated by a wash-out period</description>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_label>Treatment period 2</arm_group_label>
    <arm_group_label>Treatment period 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin A1c) above 7 %&#xD;
&#xD;
          -  BMI (body mass index) below 32 kg/m^2&#xD;
&#xD;
          -  FBG (fasting blood glucose) after wash out period 130-220 mg/dl&#xD;
&#xD;
          -  Currently treated with diet or OHA (oral hypoglycaemic agent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current systemic treatment with concomitant medication&#xD;
&#xD;
          -  Known or suspected history of drug or alcohol dependence&#xD;
&#xD;
          -  Any other significant concomitant disease such as cerebrovascular or symptomatic&#xD;
             peripheral vascular disease, malignant, disease or severe treated or untreated&#xD;
             hypertension&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  Cardiac problems&#xD;
&#xD;
          -  Active proliferative retinopathy&#xD;
&#xD;
          -  Known or suspected allergy to trial product or related products&#xD;
&#xD;
          -  Women in fertile age and women having the intention of becoming pregnant&#xD;
&#xD;
          -  Body Mass Index (BMI) above 32 kg/m^2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 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>Padova</city>
        <zip>35137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)</citation>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 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>Glyburide</mesh_term>
    <mesh_term>Repaglinide</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/NCT01698931
org study id: AGEE-1259
nct id: NCT01698931
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of
      repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2
      diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Basal hepatic glucose production
time frame: Day 0; day 44
measure: Number of hypoglycaemic episodes
time frame: Day 0; day 44
measure: Change in body weight
time frame: Day 0; day 44
measure: Number of adverse events
time frame: Day 0; day 44
arm group label: Treatment period 1
arm group type: Experimental
arm group label: Treatment period 2
arm group type: Active Comparator
arm group label: Treatment period 3
arm group type: Placebo Comparator
intervention type: Drug
intervention name: repaglinide
description: 1 mg before each main meal on three separate dosing visits separated by a wash-out period
arm group label: Treatment period 1
arm group label: Treatment period 2
arm group label: Treatment period 3
intervention type: Drug
intervention name: glyburide
description: 5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
arm group label: Treatment period 1
arm group label: Treatment period 2
arm group label: Treatment period 3
intervention type: Drug
intervention name: placebo
description: Before each main meal on three separate dosing visits separated by a wash-out period
arm group label: Treatment period 1
arm group label: Treatment period 2
arm group label: Treatment period 3
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Italy
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Glyburide
mesh term: Repaglinide