<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/NCT02248714</url>
  </required_header>
  <id_info>
    <org_study_id>2010-32</org_study_id>
    <nct_id>NCT02248714</nct_id>
  </id_info>
  <brief_title>The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes</brief_title>
  <official_title>A 4-week, Single-center, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Glucerna SR Using Continuous Glucose Monitoring System(CGMS) in Chinese Drug-naïve Subjects With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed&#xD;
      type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS&#xD;
      (continuous glucose monitoring system) and to further realize the safety and effect of&#xD;
      Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic&#xD;
      response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated&#xD;
      fatty acids, which can help keep good metabolic state in accordance with the recommendations&#xD;
      of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna&#xD;
      SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the&#xD;
      application of CGMS (continuous glucose monitoring system) and to further realize the safety&#xD;
      and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and&#xD;
      day-to-day amplitude of blood glucose fluctuation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in AUCpp</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in SDBG</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in MAGE</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Glucose Coefficient of Variation(CV)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BMI</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of BMI between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of systolic blood pressure between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diastolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of diastolic blood pressure between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in TC</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of total cholesterol between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Triglycerides</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of triglycerides between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HDL-c</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of HDL-c between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in LDL-c</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of LDL-c between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FPG</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of FPG between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2h-PG</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of 2h-PG between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HbA1c</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of HbA1c between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in GA</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of GA between the end and the beginning of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HOMA-IR</measure>
    <time_frame>4 weeks</time_frame>
    <description>the change of HOMA-IR between the end and the beginning of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucerna SR</intervention_name>
    <description>Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
    <arm_group_label>Study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed type 2 diabetes mellitus&#xD;
&#xD;
          -  FPG≤13mmol/l and/or 2hPG≤18mmol/l&#xD;
&#xD;
          -  HbA1c≥7.0%&#xD;
&#xD;
          -  BMI (Body Mass Index)≥18.5kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients taking any class of injectible or oral hypoglycemia agents to manage their&#xD;
             hyperglycemia.&#xD;
&#xD;
          -  Female patients are in gestation, lactation or intend to be pregnant in the study&#xD;
             period.&#xD;
&#xD;
          -  Patients are with type 1 diabetes, or other special types of diabetes, or gestational&#xD;
             diabetes mellitus.&#xD;
&#xD;
          -  Patients with drug hypersensitivity.&#xD;
&#xD;
          -  Patients with obvious hepatic or renal diseases (ALT, T-Bil&gt;1.5 times of upper limit)&#xD;
&#xD;
          -  Patients with severe or unstable angina, or heart failure (NYHA class III/IV)&#xD;
&#xD;
          -  Patients having acute complications, or chronic complications maintained insulin&#xD;
             therapy or insulin therapy under stress.&#xD;
&#xD;
          -  Patients with chronic consumptive diseases like cerebrovascular disease, tumor,&#xD;
             tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive&#xD;
             dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuqian Bao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>January 7, 2019</results_first_submitted>
  <results_first_submitted_qc>April 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 1, 2019</results_first_posted>
  <last_update_submitted>April 6, 2019</last_update_submitted>
  <last_update_submitted_qc>April 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</investigator_affiliation>
    <investigator_full_name>Yuqian Bao</investigator_full_name>
    <investigator_title>Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <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>December 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02248714/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Arm</title>
          <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Arm</title>
          <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</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="62"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.9" spread="9.1"/>
                    <measurement group_id="B2" value="56.5" spread="8.4"/>
                    <measurement group_id="B3" value="56.7" spread="8.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.6" spread="3.0"/>
                    <measurement group_id="B2" value="25.3" spread="2.9"/>
                    <measurement group_id="B3" value="24.9" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131.7" spread="14.8"/>
                    <measurement group_id="B2" value="128.9" spread="12.1"/>
                    <measurement group_id="B3" value="130.4" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.4" spread="9.2"/>
                    <measurement group_id="B2" value="79.7" spread="9.0"/>
                    <measurement group_id="B3" value="80.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Cholesterol (TC)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.1" spread="0.8"/>
                    <measurement group_id="B2" value="5.1" spread="1.0"/>
                    <measurement group_id="B3" value="5.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.9" spread="1.6"/>
                    <measurement group_id="B2" value="1.6" spread="0.6"/>
                    <measurement group_id="B3" value="1.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Density Lipoprotein Cholesterol(HDL-c)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.2" spread="0.3"/>
                    <measurement group_id="B2" value="1.2" spread="0.2"/>
                    <measurement group_id="B3" value="1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low Density Lipoprotein Cholesterol(LDL-c)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" spread="0.8"/>
                    <measurement group_id="B2" value="3.2" spread="0.8"/>
                    <measurement group_id="B3" value="3.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Plasma Glucose (FPG)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.4" spread="0.8"/>
                    <measurement group_id="B2" value="7.4" spread="1.2"/>
                    <measurement group_id="B3" value="7.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>2-h Plasma Glucose (2h-PG)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.0" spread="2.7"/>
                    <measurement group_id="B2" value="15.0" spread="2.6"/>
                    <measurement group_id="B3" value="15.0" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated Hemoglobin A1c (HbA1c)</title>
          <units>percentage of glycated hemoglobin A1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2" spread="0.6"/>
                    <measurement group_id="B2" value="7.2" spread="0.6"/>
                    <measurement group_id="B3" value="7.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated Albumin (GA)</title>
          <units>percentage of glycated albumin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.1" spread="2.8"/>
                    <measurement group_id="B2" value="17.7" spread="2.9"/>
                    <measurement group_id="B3" value="17.9" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Homeostasis Model Assessments of Insulin Resistance (HOMA-IR)</title>
          <units>mU/L*mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.2" spread="2.9"/>
                    <measurement group_id="B2" value="4.3" spread="2.4"/>
                    <measurement group_id="B3" value="4.3" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Incremental AUC of Postprandial Blood Glucose (AUCpp)</title>
          <units>min*mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="522.5" spread="335.9"/>
                    <measurement group_id="B2" value="479.4" spread="236.8"/>
                    <measurement group_id="B3" value="501.1" spread="290.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Standard Deviation of Blood Glucose (SDBG)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.9" spread="0.7"/>
                    <measurement group_id="B2" value="1.8" spread="0.6"/>
                    <measurement group_id="B3" value="1.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Amplitude of Glycaemic Excursions (MAGE)</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.0" spread="2.0"/>
                    <measurement group_id="B2" value="4.8" spread="1.7"/>
                    <measurement group_id="B3" value="4.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glucose Coefficient of Variation(CV)</title>
          <description>glucose coefficient of variation (CV) was calculated by dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.</description>
          <units>percentage of CV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                    <count group_id="B2" value="61"/>
                    <count group_id="B3" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.5" spread="7.3"/>
                    <measurement group_id="B2" value="20.9" spread="5.6"/>
                    <measurement group_id="B3" value="21.2" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in AUCpp</title>
        <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AUCpp</title>
          <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>min*mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-287.8" spread="368.7"/>
                    <measurement group_id="O2" value="-31.2" spread="301.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in SDBG</title>
        <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SDBG</title>
          <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.8"/>
                    <measurement group_id="O2" value="-0.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in MAGE</title>
        <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MAGE</title>
          <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.3"/>
                    <measurement group_id="O2" value="-0.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glucose Coefficient of Variation(CV)</title>
        <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glucose Coefficient of Variation(CV)</title>
          <description>Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>percentage of CV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="8.1"/>
                    <measurement group_id="O2" value="-0.2" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BMI</title>
        <description>the change of BMI between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI</title>
          <description>the change of BMI between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.5"/>
                    <measurement group_id="O2" value="-0.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure</title>
        <description>the change of systolic blood pressure between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure</title>
          <description>the change of systolic blood pressure between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="11.8"/>
                    <measurement group_id="O2" value="-2.8" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diastolic Blood Pressure</title>
        <description>the change of diastolic blood pressure between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diastolic Blood Pressure</title>
          <description>the change of diastolic blood pressure between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="10.8"/>
                    <measurement group_id="O2" value="-1.1" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in TC</title>
        <description>the change of total cholesterol between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in TC</title>
          <description>the change of total cholesterol between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.7"/>
                    <measurement group_id="O2" value="-0.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Triglycerides</title>
        <description>the change of triglycerides between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Triglycerides</title>
          <description>the change of triglycerides between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.3"/>
                    <measurement group_id="O2" value="-0.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HDL-c</title>
        <description>the change of HDL-c between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HDL-c</title>
          <description>the change of HDL-c between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="0.1"/>
                    <measurement group_id="O2" value="0.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in LDL-c</title>
        <description>the change of LDL-c between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in LDL-c</title>
          <description>the change of LDL-c between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.6"/>
                    <measurement group_id="O2" value="-0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FPG</title>
        <description>the change of FPG between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FPG</title>
          <description>the change of FPG between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.9"/>
                    <measurement group_id="O2" value="-0.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 2h-PG</title>
        <description>the change of 2h-PG between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 2h-PG</title>
          <description>the change of 2h-PG between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="3.3"/>
                    <measurement group_id="O2" value="-2.0" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HbA1c</title>
        <description>the change of HbA1c between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c</title>
          <description>the change of HbA1c between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.4"/>
                    <measurement group_id="O2" value="-0.5" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in GA</title>
        <description>the change of GA between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in GA</title>
          <description>the change of GA between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>percentage of GA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="2.6"/>
                    <measurement group_id="O2" value="-1.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HOMA-IR</title>
        <description>the change of HOMA-IR between the end and the beginning of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>The analysis population is subjects who completed the whole study.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Arm</title>
            <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HOMA-IR</title>
          <description>the change of HOMA-IR between the end and the beginning of the study</description>
          <population>The analysis population is subjects who completed the whole study.</population>
          <units>mU/L*mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="2.2"/>
                    <measurement group_id="O2" value="-1.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <desc>The subjects are newly diagnosed and untreated T2D, so they are not prone to hypoglycemia.</desc>
      <group_list>
        <group group_id="E1">
          <title>Study Arm</title>
          <description>Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)&#xD;
Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.</description>
        </group>
      </group_list>
      <serious_events>
        <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="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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>
    <limitations_and_caveats>1.The intervention period was relatively short. 2. The open-label design of the current study may introduce some extent of bias. 3.Only untreated T2D patients were admitted in the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Yuqian Bao</name_or_title>
      <organization>6thShanghaiJiaotongU</organization>
      <phone>(021)64369181</phone>
      <email>byq522@163.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02248714
org study id: 2010-32
nct id: NCT02248714
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed
      type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS
      (continuous glucose monitoring system) and to further realize the safety and effect of
      Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic
      response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated
      fatty acids, which can help keep good metabolic state in accordance with the recommendations
      of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna
      SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the
      application of CGMS (continuous glucose monitoring system) and to further realize the safety
      and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and
      day-to-day amplitude of blood glucose fluctuation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in AUCpp
time frame: 4 weeks
description: Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.
measure: Change From Baseline in SDBG
time frame: 4 weeks
description: Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.
measure: Change From Baseline in MAGE
time frame: 4 weeks
description: Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.
measure: Change From Baseline in Glucose Coefficient of Variation(CV)
time frame: 4 weeks
description: Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.
measure: Change From Baseline in BMI
time frame: 4 weeks
description: the change of BMI between the end and the beginning of the study
measure: Change From Baseline in Systolic Blood Pressure
time frame: 4 weeks
description: the change of systolic blood pressure between the end and the beginning of the study
measure: Change From Baseline in Diastolic Blood Pressure
time frame: 4 weeks
description: the change of diastolic blood pressure between the end and the beginning of the study
measure: Change From Baseline in TC
time frame: 4 weeks
description: the change of total cholesterol between the end and the beginning of the study
measure: Change From Baseline in Triglycerides
time frame: 4 weeks
description: the change of triglycerides between the end and the beginning of the study
measure: Change From Baseline in HDL-c
time frame: 4 weeks
description: the change of HDL-c between the end and the beginning of the study
measure: Change From Baseline in LDL-c
time frame: 4 weeks
description: the change of LDL-c between the end and the beginning of the study
measure: Change From Baseline in FPG
time frame: 4 weeks
description: the change of FPG between the end and the beginning of the study
measure: Change From Baseline in 2h-PG
time frame: 4 weeks
description: the change of 2h-PG between the end and the beginning of the study
measure: Change From Baseline in HbA1c
time frame: 4 weeks
description: the change of HbA1c between the end and the beginning of the study
measure: Change From Baseline in GA
time frame: 4 weeks
description: the change of GA between the end and the beginning of the study
measure: Change From Baseline in HOMA-IR
time frame: 4 weeks
description: the change of HOMA-IR between the end and the beginning of the study
arm group label: Study arm
arm group type: Experimental
description: Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)
arm group label: Control arm
arm group type: No Intervention
description: Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.
intervention type: Dietary Supplement
intervention name: Glucerna SR
description: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
arm group label: Study arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yuqian Bao, MD
role: Principal Investigator
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
investigator full name: Yuqian Bao
investigator title: Director of the Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 1.The intervention period was relatively short. 2. The open-label design of the current study may introduce some extent of bias. 3.Only untreated T2D patients were admitted in the study.
point of contact: 