<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/NCT03013985</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00091740</org_study_id>
    <nct_id>NCT03013985</nct_id>
  </id_info>
  <brief_title>Glargine U300 Hospital Trial</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if treatment with Glargine U300 when compared to&#xD;
      Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),&#xD;
      who are admitted to the hospital and then transition at home, after discharge from the&#xD;
      hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several randomized clinical trials done previously in medicine and surgical patients with T2D&#xD;
      have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose&#xD;
      (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in&#xD;
      lower rate of hospital complications. Glargine U300 results in similar improvement but in&#xD;
      lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however,&#xD;
      have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and&#xD;
      diabetes in the hospital setting. This study will determine if treatment with glargine U300&#xD;
      has a similar glucose control in patients with diabetes admitted to the hospital and if&#xD;
      glargine U300 will result in lower number of low blood sugars compared to glargine U100 .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Daily Blood Glucose Concentration Inpatient</measure>
    <time_frame>up to 10 days (day of hospital discharge)</time_frame>
    <description>The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Daily Blood Glucose Concentration After Hospital Discharge</measure>
    <time_frame>assessed from day 11 (day after hospital discharge) up to 3 months</time_frame>
    <description>Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%</measure>
    <time_frame>up to 3 months post enrollment</time_frame>
    <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%</measure>
    <time_frame>up to 3 months post enrollment</time_frame>
    <description>Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days</measure>
    <time_frame>Up to 3 days</time_frame>
    <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Blood Glucose 70-180 Measured by Point of Care Test</measure>
    <time_frame>3 months post enrollment</time_frame>
    <description>Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Subjects With Hypoglycemic Events</measure>
    <time_frame>3 months post enrollment</time_frame>
    <description>Percent of of subjects with hypoglycemic events (BG &lt; 70 mg/dl) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Subjects With Severe Hypoglycemia</measure>
    <time_frame>3 months post enrollment</time_frame>
    <description>Percent of subjects experiencing severe hypoglycemia (BG &lt;54 mg/dl) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days of Hospital Stay</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>The number of days of hospital stay for each subject will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number Subjects With Cardiac Complications</measure>
    <time_frame>3 months post enrollment</time_frame>
    <description>The number of subjects experiencing cardiac cardiac complications will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Acute Renal Failure</measure>
    <time_frame>3 months post enrollment</time_frame>
    <description>The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine &gt; 0.5 mg/dL from baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>During hospital stay - up to 10 days</time_frame>
    <description>Number of hospital deaths that occur.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">247</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Basal bolus insulin with glargine U300 and glulisine insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal bolus insulin with glargine U100 and glulisine insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine U300</intervention_name>
    <description>Glargine U300 is a new generation long-acting insulin.</description>
    <arm_group_label>Basal bolus insulin with glargine U300 and glulisine insulin</arm_group_label>
    <other_name>Toujeo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glargine U100</intervention_name>
    <description>Glargine U100 is a long-acting insulin.</description>
    <arm_group_label>Basal bolus insulin with glargine U100 and glulisine insulin</arm_group_label>
    <other_name>Lantus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glulisine Insulin</intervention_name>
    <description>Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
    <arm_group_label>Basal bolus insulin with glargine U100 and glulisine insulin</arm_group_label>
    <arm_group_label>Basal bolus insulin with glargine U300 and glulisine insulin</arm_group_label>
    <other_name>Apidra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females between &gt; 18 years admitted to a general medicine or surgical&#xD;
             service.&#xD;
&#xD;
          -  Known histories of T2D treated with either diet alone, oral monotherapy, any&#xD;
             combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide)&#xD;
             or insulin therapy with the exception of degludec and glargine U300.&#xD;
&#xD;
          -  Subjects must have an admission/randomization BG &gt; 140 mg and &lt; 400 mg/dL without&#xD;
             laboratory evidence of diabetic ketoacidosis (bicarbonate &lt; 18 mEq/L, pH &lt; 7.30, or&#xD;
             positive serum or urinary ketones).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with increased BG concentration, but without a known history of diabetes.&#xD;
&#xD;
          -  Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA&#xD;
             (weekly exenatide, dulaglutide or albiglutide).&#xD;
&#xD;
          -  Patients with acute critical or surgical illness admitted to the ICU or expected to&#xD;
             require admission to the ICU.&#xD;
&#xD;
          -  Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and&#xD;
             portal hypertension), corticosteroid therapy, or impaired renal function (eGFR&lt; 30&#xD;
             ml/min).&#xD;
&#xD;
          -  Mental condition rendering the subject unable to understand the nature, scope, and&#xD;
             possible consequences of the study.&#xD;
&#xD;
          -  Female subjects who are pregnant or breast feeding at time of enrollment into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Umpierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>March 23, 2020</results_first_submitted>
  <results_first_submitted_qc>April 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2020</results_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Guillermo Umpierrez, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Blood glucose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin glulisine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03013985/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03013985/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Out of 247 consented, 9 were not randomized, 27 failed to start (19 did not receive study medication, 1 had eGFR out of range, 7 had admission BG &gt;400 mg/dl)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
        </group>
        <group group_id="P2">
          <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
        </group>
        <group group_id="B2">
          <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</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="108"/>
            <count group_id="B2" value="103"/>
            <count group_id="B3" value="211"/>
          </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="57.2" spread="12.1"/>
                    <measurement group_id="B2" value="56.3" spread="12.4"/>
                    <measurement group_id="B3" value="56.7" spread="12.2"/>
                  </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="46"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Daily Blood Glucose Concentration Inpatient</title>
        <description>The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.</description>
        <time_frame>up to 10 days (day of hospital discharge)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Blood Glucose Concentration Inpatient</title>
          <description>The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186" spread="40"/>
                    <measurement group_id="O2" value="184" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Daily Blood Glucose Concentration After Hospital Discharge</title>
        <description>Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.</description>
        <time_frame>assessed from day 11 (day after hospital discharge) up to 3 months</time_frame>
        <population>The outpatient has less number of participants compared to the in-hospital part due to a1c less tan required for outpatient part, participants not wanting to continue in the discharge part and/or admission to long term facilities where we were not able to administer study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Blood Glucose Concentration After Hospital Discharge</title>
          <description>Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.</description>
          <population>The outpatient has less number of participants compared to the in-hospital part due to a1c less tan required for outpatient part, participants not wanting to continue in the discharge part and/or admission to long term facilities where we were not able to administer study medication.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.6" spread="44.8"/>
                    <measurement group_id="O2" value="164.5" spread="46.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%</title>
        <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.</description>
        <time_frame>up to 3 months post enrollment</time_frame>
        <population>subjects with HbA1c lower than 8% at admission</population>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%</title>
          <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.</description>
          <population>subjects with HbA1c lower than 8% at admission</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" spread="14.4"/>
                    <measurement group_id="O2" value="134.4" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%</title>
        <description>Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded</description>
        <time_frame>up to 3 months post enrollment</time_frame>
        <population>Patients with admission HbA1c higher than 8%</population>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%</title>
          <description>Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded</description>
          <population>Patients with admission HbA1c higher than 8%</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.3" spread="38.5"/>
                    <measurement group_id="O2" value="155.6" spread="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days</title>
        <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days</description>
        <time_frame>Up to 3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days</title>
          <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.71" spread="42.35"/>
                    <measurement group_id="O2" value="196.72" spread="56.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days</title>
        <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days</description>
        <time_frame>Up to 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days</title>
          <description>Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.53" spread="43.1"/>
                    <measurement group_id="O2" value="193.64" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days</title>
        <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.</description>
        <time_frame>Up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days</title>
          <description>Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188.46" spread="34.7"/>
                    <measurement group_id="O2" value="174.55" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Blood Glucose 70-180 Measured by Point of Care Test</title>
        <description>Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test</description>
        <time_frame>3 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Blood Glucose 70-180 Measured by Point of Care Test</title>
          <description>Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test</description>
          <units>percentage of BG readings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.3" spread="27.5"/>
                    <measurement group_id="O2" value="54.9" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Subjects With Hypoglycemic Events</title>
        <description>Percent of of subjects with hypoglycemic events (BG &lt; 70 mg/dl) will be recorded.</description>
        <time_frame>3 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects With Hypoglycemic Events</title>
          <description>Percent of of subjects with hypoglycemic events (BG &lt; 70 mg/dl) will be recorded.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                    <measurement group_id="O2" value="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Subjects With Severe Hypoglycemia</title>
        <description>Percent of subjects experiencing severe hypoglycemia (BG &lt;54 mg/dl) will be recorded.</description>
        <time_frame>3 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Subjects With Severe Hypoglycemia</title>
          <description>Percent of subjects experiencing severe hypoglycemia (BG &lt;54 mg/dl) will be recorded.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days of Hospital Stay</title>
        <description>The number of days of hospital stay for each subject will be recorded.</description>
        <time_frame>Up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days of Hospital Stay</title>
          <description>The number of days of hospital stay for each subject will be recorded.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4" upper_limit="8"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number Subjects With Cardiac Complications</title>
        <description>The number of subjects experiencing cardiac cardiac complications will be recorded.</description>
        <time_frame>3 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Number Subjects With Cardiac Complications</title>
          <description>The number of subjects experiencing cardiac cardiac complications will be recorded.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Acute Renal Failure</title>
        <description>The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine &gt; 0.5 mg/dL from baseline).</description>
        <time_frame>3 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Acute Renal Failure</title>
          <description>The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine &gt; 0.5 mg/dL from baseline).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Mortality</title>
        <description>Number of hospital deaths that occur.</description>
        <time_frame>During hospital stay - up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
          <group group_id="O2">
            <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
            <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Mortality</title>
          <description>Number of hospital deaths that occur.</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Basal Bolus Insulin With Glargine U300 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U300: Glargine U300 is a new generation long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
        </group>
        <group group_id="E2">
          <title>Basal Bolus Insulin With Glargine U100 and Glulisine Insulin</title>
          <description>Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.&#xD;
Glargine U100: Glargine U100 is a long-acting insulin.&#xD;
Glulisine Insulin: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="108"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Chronic Heart Failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="108"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroentestinal disorder</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="108"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Surgery</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>ICU admission</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Skin graft failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Numbness on right side of body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </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="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Malfunctioning Peripherally Inserted Central Catheter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="10" subjects_at_risk="108"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic heart failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen Impaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Leg Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Trauma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Tremors</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Polysubstance abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Scrotal Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma exacerbation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Social (homelessness)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Skin Graft revision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wound Check</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="108"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Guillermo Umpierrez</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-1665</phone>
      <email>GEUMPIE@emory.edu</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/NCT03013985
org study id: IRB00091740
nct id: NCT03013985
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to find out if treatment with Glargine U300 when compared to
      Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),
      who are admitted to the hospital and then transition at home, after discharge from the
      hospital.
Several randomized clinical trials done previously in medicine and surgical patients with T2D
      have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose
      (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in
      lower rate of hospital complications. Glargine U300 results in similar improvement but in
      lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however,
      have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and
      diabetes in the hospital setting. This study will determine if treatment with glargine U300
      has a similar glucose control in patients with diabetes admitted to the hospital and if
      glargine U300 will result in lower number of low blood sugars compared to glargine U100 .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Daily Blood Glucose Concentration Inpatient
time frame: up to 10 days (day of hospital discharge)
description: The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.
measure: Mean Daily Blood Glucose Concentration After Hospital Discharge
time frame: assessed from day 11 (day after hospital discharge) up to 3 months
description: Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.
measure: Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
time frame: up to 3 months post enrollment
description: Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.
measure: Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
time frame: up to 3 months post enrollment
description: Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded
measure: Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
time frame: Up to 3 days
description: Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days
measure: Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
time frame: Up to 5 days
description: Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days
measure: Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
time frame: Up to 10 days
description: Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.
measure: Percent of Blood Glucose 70-180 Measured by Point of Care Test
time frame: 3 months post enrollment
description: Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test
measure: Percent of Subjects With Hypoglycemic Events
time frame: 3 months post enrollment
description: Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.
measure: Percent of Subjects With Severe Hypoglycemia
time frame: 3 months post enrollment
description: Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.
measure: Number of Days of Hospital Stay
time frame: Up to 10 days
description: The number of days of hospital stay for each subject will be recorded.
measure: Number Subjects With Cardiac Complications
time frame: 3 months post enrollment
description: The number of subjects experiencing cardiac cardiac complications will be recorded.
measure: Number of Patients With Acute Renal Failure
time frame: 3 months post enrollment
description: The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline).
measure: Hospital Mortality
time frame: During hospital stay - up to 10 days
description: Number of hospital deaths that occur.
arm group label: Basal bolus insulin with glargine U300 and glulisine insulin
arm group type: Experimental
description: Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
arm group label: Basal bolus insulin with glargine U100 and glulisine insulin
arm group type: Active Comparator
description: Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
intervention type: Drug
intervention name: Glargine U300
description: Glargine U300 is a new generation long-acting insulin.
arm group label: Basal bolus insulin with glargine U300 and glulisine insulin
other name: Toujeo
intervention type: Drug
intervention name: Glargine U100
description: Glargine U100 is a long-acting insulin.
arm group label: Basal bolus insulin with glargine U100 and glulisine insulin
other name: Lantus
intervention type: Drug
intervention name: Glulisine Insulin
description: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
arm group label: Basal bolus insulin with glargine U100 and glulisine insulin
arm group label: Basal bolus insulin with glargine U300 and glulisine insulin
other name: Apidra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillermo Umpierrez, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Guillermo Umpierrez, MD
investigator title: Professor
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine
mesh term: Insulin glulisine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 