<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/NCT01681290</url>
  </required_header>
  <id_info>
    <org_study_id>CBX129801-DN-201</org_study_id>
    <nct_id>NCT01681290</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes</brief_title>
  <official_title>A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cebix Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cebix Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated&#xD;
      synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type&#xD;
      1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy&#xD;
      (DPN).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bilateral change in sensory nerve conduction velocity</measure>
    <time_frame>Predose and 12 months post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vibration perception threshold</measure>
    <time_frame>Predose and 6 and 12 months post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical composite score</measure>
    <time_frame>Predose and 6 and 12 months post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity due to DPN</measure>
    <time_frame>Predose and 12 months post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function questionnaires</measure>
    <time_frame>Predose and 6 and 12 months post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>Predose and 12 months post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>CBX129801 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solution for injection, 2.4 mg, weekly for 52 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBX129801 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solution for injection, 0.8 mg, weekly for 52 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Solution for injection, vehicle with no active, weekly for 52 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CBX129801</intervention_name>
    <arm_group_label>CBX129801 High Dose</arm_group_label>
    <arm_group_label>CBX129801 Low Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Give informed consent;&#xD;
&#xD;
          -  18-65 years old;&#xD;
&#xD;
          -  Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen&#xD;
             (for at least 3 months);&#xD;
&#xD;
          -  Have clinical signs of diabetic peripheral neuropathy at screening;&#xD;
&#xD;
          -  Have abnormal sural nerve conduction observed bilaterally during screening;&#xD;
&#xD;
          -  Be C-peptide deficient;&#xD;
&#xD;
          -  Be in good general health (besides having type 1 diabetes mellitus);&#xD;
&#xD;
          -  Practice effective contraception during and for at least 12 weeks after study&#xD;
             participation;&#xD;
&#xD;
          -  Have a body mass index (BMI) ≥18.0 and &lt;35.0 kg/m2.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Any significant cardiovascular, hematological, lymphatic, immunologic, urologic,&#xD;
             dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes&#xD;
             mellitus), central nervous, gastrointestinal, or other major disease;&#xD;
&#xD;
          -  Unstable or inadequate glucose control;&#xD;
&#xD;
          -  Any clinically significant laboratory value at screening;&#xD;
&#xD;
          -  Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the&#xD;
             assistance of another individual) within 6 months of Day 0, or recurrent episodes of&#xD;
             non-severe hypoglycemia (≥3 per week on average) that are deemed clinically&#xD;
             significant by the Investigator;&#xD;
&#xD;
          -  Have had an islet cell, kidney, and/or pancreas transplant;&#xD;
&#xD;
          -  If female, is pregnant or lactating;&#xD;
&#xD;
          -  History of alcohol or substance abuse within 2 years;&#xD;
&#xD;
          -  Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus&#xD;
             (HIV) antibody;&#xD;
&#xD;
          -  Initiation of treatment or change of dose of medication that could affect peripheral&#xD;
             nerve function within 60 days;&#xD;
&#xD;
          -  Previous treatment with CBX129801 or unmodified C-peptide;&#xD;
&#xD;
          -  Receipt of an investigational product or therapeutic device, or participation in a&#xD;
             drug research study, within a period of 30 days;&#xD;
&#xD;
          -  Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Kim, MD</last_name>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <zip>59701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linköping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malmo</city>
        <zip>20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Umea</city>
        <zip>90185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>January 28, 2015</last_update_submitted>
  <last_update_submitted_qc>January 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 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>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</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/NCT01681290
org study id: CBX129801-DN-201
nct id: NCT01681290
lead sponsor: 
has dmc: No
The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated
      synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type
      1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy
      (DPN).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bilateral change in sensory nerve conduction velocity
time frame: Predose and 12 months post dose
measure: Vibration perception threshold
time frame: Predose and 6 and 12 months post dose
measure: Clinical composite score
time frame: Predose and 6 and 12 months post dose
measure: Pain Intensity due to DPN
time frame: Predose and 12 months post dose
measure: Sexual function questionnaires
time frame: Predose and 6 and 12 months post dose
measure: Quality of life questionnaire
time frame: Predose and 12 months post dose
arm group label: CBX129801 High Dose
arm group type: Experimental
description: Solution for injection, 2.4 mg, weekly for 52 weeks
arm group label: CBX129801 Low Dose
arm group type: Experimental
description: Solution for injection, 0.8 mg, weekly for 52 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Solution for injection, vehicle with no active, weekly for 52 weeks
intervention type: Drug
intervention name: CBX129801
arm group label: CBX129801 High Dose
arm group label: CBX129801 Low Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dennis Kim, MD
affiliation: Chief Medical Officer
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country: Canada
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies