<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/NCT02229383</url>
  </required_header>
  <id_info>
    <org_study_id>D5553C00002</org_study_id>
    <secondary_id>2014-003502-33</secondary_id>
    <nct_id>NCT02229383</nct_id>
  </id_info>
  <brief_title>Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel&#xD;
      group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added&#xD;
      to titrated basal insulin glargine with or without metformin to placebo added to titrated&#xD;
      basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus&#xD;
      (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added&#xD;
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added&#xD;
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the&#xD;
      28-week treatment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2014</start_date>
  <completion_date type="Actual">August 29, 2016</completion_date>
  <primary_completion_date type="Actual">August 29, 2016</primary_completion_date>
  <phase>Phase 3</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 in HbA1c From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the percentage of participants achieving HbA1c &lt;7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 28 in Daily Insulin Dose</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the percentage of participants achieving HbA1c &lt;7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Seated Systolic Blood Pressure From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">464</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Exenatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exenatide</intervention_name>
    <description>2 mg weekly suspension injection</description>
    <arm_group_label>Exenatide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exenatide matching placebo</intervention_name>
    <description>Once weekly Placebo injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)&#xD;
&#xD;
          -  Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).&#xD;
&#xD;
          -  Has fasting plasma glucose (FPG) concentration &lt;280 mg/dL (15.6 mmol/L) at Visit 1&#xD;
             (Screening)&#xD;
&#xD;
          -  Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least&#xD;
             6 weeks prior to Screening, in combination with diet and exercise alone or in&#xD;
             combination with:&#xD;
&#xD;
               1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1&#xD;
&#xD;
               2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1&#xD;
                  (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the&#xD;
                  Screening visit&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)&#xD;
&#xD;
          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride&#xD;
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1&#xD;
&#xD;
          -  Positive serological test for hepatitis B or hepatitis C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <zip>35662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33437</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiefland</city>
        <state>Florida</state>
        <zip>32626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Franklin</city>
        <state>Indiana</state>
        <zip>46131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haddon Heights</city>
        <state>New Jersey</state>
        <zip>08035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morganton</city>
        <state>North Carolina</state>
        <zip>28655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Orchard</city>
        <state>Washington</state>
        <zip>98366</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Balatonfured</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1033</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gödöllő</city>
        <zip>2100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komárom</city>
        <zip>2921</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Létavértes</city>
        <zip>4281</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pécs</city>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Satoraljaujhely</city>
        <zip>3980</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
        <zip>6722</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szekszárd</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-538</zip>
        <country>Poland</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oświęcim</city>
        <zip>32-600</zip>
        <country>Poland</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-655</zip>
        <country>Poland</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torun</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zamość</city>
        <zip>22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zgierz</city>
        <zip>95-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Łódź</city>
        <zip>94-048</zip>
        <country>Poland</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baia Mare</city>
        <zip>430222</zip>
        <country>Romania</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>010192</zip>
        <country>Romania</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Galati</city>
        <zip>800578</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <zip>410032</zip>
        <country>Romania</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <zip>410169</zip>
        <country>Romania</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ploiesti</city>
        <zip>100342</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tg Mures</city>
        <zip>540142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Timișoara</city>
        <zip>300456</zip>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bardejov</city>
        <zip>08501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>81108</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>82106</zip>
        <country>Slovakia</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dolny Kubin</city>
        <zip>026 01</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kosice</city>
        <zip>04001</zip>
        <country>Slovakia</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levice</city>
        <zip>934 01</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levice</city>
        <zip>93401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lucenec</city>
        <zip>984 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nitra</city>
        <zip>94901</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nitra</city>
        <zip>94911</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Presov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sturovo</city>
        <zip>94301</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kempton Park</city>
        <zip>1619</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krugersdorp</city>
        <zip>1739</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paarl</city>
        <zip>7646</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pretoria</city>
        <zip>0087</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pretoria</city>
        <zip>184</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Somerset West</city>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Worcester</city>
        <zip>6850</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>August 18, 2017</results_first_submitted>
  <results_first_submitted_qc>August 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2017</results_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Exenatide</keyword>
  <keyword>Diabetes drug</keyword>
  <keyword>Treatment efficacy</keyword>
  <keyword>Placebo</keyword>
  <keyword>Metabolism</keyword>
  <keyword>Cardiovascilar metabolic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exenatide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted in 107 centers globally between 06 September 2014 and 29 August 2016.</recruitment_details>
      <pre_assignment_details>The study had a Screening Visit, an 8-week insulin dose optimization phase, followed by a 28-week randomized, double-blind treatment phase. A total of 464 participants were randomized and entered the double-blind Treatment Period. Of which, 3 participants from 1 center in the United States have been excluded from analyses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Exenatide</title>
          <description>Exenatide 2 milligram (mg) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-treat (ITT) Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="230"/>
                <participants group_id="P2" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="212"/>
                <participants group_id="P2" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The overall number of baseline participants is comprised of the ITT analysis set: All randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline hemoglobin A1c (HbA1c) assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Exenatide</title>
          <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="230"/>
            <count group_id="B2" value="228"/>
            <count group_id="B3" value="458"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.8" spread="9.04"/>
                    <measurement group_id="B2" value="57.5" spread="10.28"/>
                    <measurement group_id="B3" value="57.7" spread="9.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian Or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black Or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian Or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in HbA1c From Baseline to Week 28</title>
        <description>To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to Week 28</title>
          <description>To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
          <units>Percentage of HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" lower_limit="-1.12" upper_limit="-0.81"/>
                    <measurement group_id="O2" value="-0.22" lower_limit="-0.38" upper_limit="-0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c (&lt; or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.101</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.94</ci_lower_limit>
            <ci_upper_limit>-0.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight From Baseline to Week 28</title>
        <description>To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight From Baseline to Week 28</title>
          <description>To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
          <units>kilogram</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" lower_limit="-1.54" upper_limit="-0.53"/>
                    <measurement group_id="O2" value="0.48" lower_limit="-0.02" upper_limit="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c (&lt; or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.341</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.19</ci_lower_limit>
            <ci_upper_limit>-0.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)</title>
        <description>To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)</title>
          <description>To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
          <units>milligram per deciliter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.73" lower_limit="-40.0" upper_limit="-17.45"/>
                    <measurement group_id="O2" value="-0.96" lower_limit="-12.41" upper_limit="10.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <method_desc>Treatment, region, baseline HbA1c (&lt; or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-27.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.754</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.07</ci_lower_limit>
            <ci_upper_limit>-16.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28</title>
        <description>To compare the percentage of participants achieving HbA1c &lt;7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28</title>
          <description>To compare the percentage of participants achieving HbA1c &lt;7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" lower_limit="26.6" upper_limit="38.7"/>
                    <measurement group_id="O2" value="7.0" lower_limit="3.7" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%) and baseline SU-use (yes vs. no).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>25.6</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 28 in Daily Insulin Dose</title>
        <description>To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 28 in Daily Insulin Dose</title>
          <description>To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
          <units>Units</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="0.1" upper_limit="3.1"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2.0" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.074</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c (&lt; or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.1</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks</title>
        <description>To compare the percentage of participants achieving HbA1c &lt;7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HbA1c &lt;7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks</title>
          <description>To compare the percentage of participants achieving HbA1c &lt;7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="16.8" upper_limit="27.5"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0.3" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%) and baseline SU-use (yes vs. no).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>20.0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Seated Systolic Blood Pressure From Baseline to Week 28</title>
        <description>To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Exenatide</title>
            <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Seated Systolic Blood Pressure From Baseline to Week 28</title>
          <description>To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.</description>
          <population>The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.</population>
          <units>millimeter of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" lower_limit="-4.4" upper_limit="-0.7"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-2.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.110</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c (&lt; or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.0</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline (Day 1) up to Week 28</time_frame>
      <desc>Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Exenatide</title>
          <description>Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute stress disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Bladder neck obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="231"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="231"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="231"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At least 30 days prior to submission for publication or presentation, Authors shall provide Sponsor with such material for its review. Sponsor shall have 30 days to comment. If requested by Sponsor, Authors shall withhold material for an additional 90 days to allow for the taking of measures to establish its proprietary rights. No publication or presentation shall be made unless and until any information determined at Sponsor's sole discretion to be Confidential has been removed.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Please note that the data from 4 subjects enrolled at one site were omitted due to potential scientific misconduct at that site. Study conclusions remain unchanged.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Global Clinical Leader</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+1 302 885 1180</phone>
      <email>ClinicalTrialTransparency@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02229383
org study id: D5553C00002
secondary id: 2014-003502-33
nct id: NCT02229383
lead sponsor: 
has dmc: No
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel
      group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added
      to titrated basal insulin glargine with or without metformin to placebo added to titrated
      basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus
      (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the
      28-week treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in HbA1c From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
measure: Change in Body Weight From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
measure: Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
time frame: Baseline to Week 28
description: To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
measure: Percentage of Participants Achieving HbA1c <7.0% at Week 28
time frame: Baseline to Week 28
description: To compare the percentage of participants achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
measure: Change From Baseline to Week 28 in Daily Insulin Dose
time frame: Baseline to Week 28
description: To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
measure: Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
time frame: Baseline to Week 28
description: To compare the percentage of participants achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.
measure: Change in Seated Systolic Blood Pressure From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
arm group label: Exenatide
arm group type: Experimental
description: Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
intervention type: Drug
intervention name: Exenatide
description: 2 mg weekly suspension injection
arm group label: Exenatide
intervention type: Drug
intervention name: Exenatide matching placebo
description: Once weekly Placebo injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Hungary
country: Poland
country: Romania
country: Slovakia
country: South Africa
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Exenatide
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Please note that the data from 4 subjects enrolled at one site were omitted due to potential scientific misconduct at that site. Study conclusions remain unchanged.
point of contact: 