<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/NCT01686620</url>
  </required_header>
  <id_info>
    <org_study_id>3-201</org_study_id>
    <nct_id>NCT01686620</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)</brief_title>
  <official_title>A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biodel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biodel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to&#xD;
      insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1C</measure>
    <time_frame>Baseline and 18 week treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic event rates</measure>
    <time_frame>Baseline and 18 week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin dose</measure>
    <time_frame>Baseline and 18 week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily blood glucose measures</measure>
    <time_frame>Baseline and 18 week treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>BIOD-123</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BIOD-123 used as prandial insulin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lispro (Humalog)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lispro (Humalog) used as prandial insulin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIOD-123</intervention_name>
    <arm_group_label>BIOD-123</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lispro (Humalog)</intervention_name>
    <arm_group_label>Lispro (Humalog)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established clinical diagnosis of type 1 diabetes, consistent with ADA classification&#xD;
             criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.&#xD;
&#xD;
          -  Age: 18 years old, or older.&#xD;
&#xD;
          -  Body Mass Index: between 18 and 35 kg/m2, inclusive.&#xD;
&#xD;
          -  Willing to use insulin glargine as the only basal insulin throughout the duration of&#xD;
             the trial.&#xD;
&#xD;
          -  Willingness not to use insulin pump treatment and only use the study glucose meter and&#xD;
             CGM devices during the duration of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of known hypersensitivity to any of the components in the study medication&#xD;
&#xD;
          -  Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated&#xD;
             use of these medications during the course of the study.&#xD;
&#xD;
          -  Treatment with oral or intravenous corticosteroids in the last 3 months prior to&#xD;
             screening. Standard doses of inhalational corticosteroid used as part of a long term&#xD;
             treatment regimen are allowed.&#xD;
&#xD;
          -  Consistent recent hypoglycemic unawareness within the last six months&#xD;
&#xD;
          -  History of more than two severe hypoglycemic events within six months prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Research Institute</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Physician Network Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Whittier Diabetes Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice - Richard Cherlin, MD.</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research Pharmaseek</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monteagle Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mills-Peninsula Health Services</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Diabetes and Endocrine Care</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Diabetes Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research Pharmaseek</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Associates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309-1764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine Research Solutions</name>
      <address>
        <city>Roswell</city>
        <state>Georgia</state>
        <zip>30076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Diabetes and Osteoporosis Center PA</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Diabetes Associates, PA</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Diabetes</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes &amp; Glandular Disease Research</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercury Street Medical</name>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <zip>59701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Endocrinolgy</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Foundation of SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes &amp; Endocrinology Consultants, PC</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentral Clinical Research Services, LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Diabetes &amp; Endrocrine Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Diabetes and Endocrine Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Endocrine Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sonterra Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Clinical Research Center</name>
      <address>
        <city>Olympia</city>
        <state>Washington</state>
        <zip>98502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ranier Clinical Research, Inc</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockwood Clinic</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <disposition_first_submitted>July 22, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>July 22, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 28, 2015</disposition_first_posted>
  <last_update_submitted>July 22, 2015</last_update_submitted>
  <last_update_submitted_qc>July 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mealtime insulin</keyword>
  <keyword>Ultra-rapid acting insulin</keyword>
  <keyword>Prandial insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Lispro</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01686620
org study id: 3-201
nct id: NCT01686620
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to
      insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1
      diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1C
time frame: Baseline and 18 week treatment period
measure: Hypoglycemic event rates
time frame: Baseline and 18 week treatment period
measure: Insulin dose
time frame: Baseline and 18 week treatment period
measure: Daily blood glucose measures
time frame: Baseline and 18 week treatment period
arm group label: BIOD-123
arm group type: Experimental
description: BIOD-123 used as prandial insulin
arm group label: Lispro (Humalog)
arm group type: Active Comparator
description: Lispro (Humalog) used as prandial insulin
intervention type: Drug
intervention name: BIOD-123
arm group label: BIOD-123
intervention type: Drug
intervention name: Lispro (Humalog)
arm group label: Lispro (Humalog)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Lispro