<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/NCT01665352</url>
  </required_header>
  <id_info>
    <org_study_id>TTP054-201</org_study_id>
    <nct_id>NCT01665352</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes</brief_title>
  <official_title>Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>vTv Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>vTv Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and effect of TTP054 versus placebo on&#xD;
      glucose control in patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in HbA1c (%) as compared to placebo</measure>
    <time_frame>Day 1 to Day 84</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting plasma glucose (mg/dL)</measure>
    <time_frame>Day 1, Day 14, Day 28, Day 56 and Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject achievement of HbA1c &lt;7%</measure>
    <time_frame>Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in body weight</measure>
    <time_frame>Day 1, Day 14, Day 28, Day 56 and Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject achievement of body weight loss ≥ 2%</measure>
    <time_frame>Day 1 and Day 84</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>TTP054 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TTP054 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TTP054 800 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TTP054</intervention_name>
    <description>Administered orally once daily for 12 weeks.</description>
    <arm_group_label>TTP054 200 mg</arm_group_label>
    <arm_group_label>TTP054 400 mg</arm_group_label>
    <arm_group_label>TTP054 800 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally once daily for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes mellitus&#xD;
&#xD;
          -  On a stable (for the last 3 months) regimen of either metformin alone or metformin in&#xD;
             combination with one additional acceptable oral antidiabetic (OAD) agent&#xD;
&#xD;
          -  HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of significant diabetic complications&#xD;
&#xD;
          -  History of heart attack, stroke or congestive heart failure&#xD;
&#xD;
          -  Severe, uncontrolled hypertension&#xD;
&#xD;
          -  Frequent hypoglycemia&#xD;
&#xD;
          -  Women of child-bearing potential&#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>Stephanie Gustavson, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>TransTech Pharma, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 18</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 13</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 5</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 3</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 17</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 7</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 8</name>
      <address>
        <city>Auburn</city>
        <state>Maine</state>
        <zip>04210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 9</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 26</name>
      <address>
        <city>Trenton</city>
        <state>New Jersey</state>
        <zip>08611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 12</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 14</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 6</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 16</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 10</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 11</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 15</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <disposition_first_submitted>April 14, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>April 14, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 6, 2015</disposition_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 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>
  <!-- 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/NCT01665352
org study id: TTP054-201
nct id: NCT01665352
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety and effect of TTP054 versus placebo on
      glucose control in patients with type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in HbA1c (%) as compared to placebo
time frame: Day 1 to Day 84
measure: Change from baseline in fasting plasma glucose (mg/dL)
time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Subject achievement of HbA1c <7%
time frame: Day 84
measure: Change from baseline in body weight
time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
measure: Subject achievement of body weight loss ≥ 2%
time frame: Day 1 and Day 84
arm group label: TTP054 400 mg
arm group type: Experimental
arm group label: TTP054 200 mg
arm group type: Experimental
arm group label: TTP054 800 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: TTP054
description: Administered orally once daily for 12 weeks.
arm group label: TTP054 200 mg
arm group label: TTP054 400 mg
arm group label: TTP054 800 mg
intervention type: Drug
intervention name: Placebo
description: Administered orally once daily for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Stephanie Gustavson, Ph.D.
role: Study Director
affiliation: TransTech Pharma, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2