<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/NCT03829891</url>
  </required_header>
  <id_info>
    <org_study_id>KY20182008-1</org_study_id>
    <nct_id>NCT03829891</nct_id>
  </id_info>
  <brief_title>Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Randomized, Open-label, Controlled,Parallel-group Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine ,&#xD;
      in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral&#xD;
      antidiabetic drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators wonder in clinical hypoglycemic treatment for patients with hyperglycemia,&#xD;
      whether to reduce fasting blood glucose or postprandial blood glucose first.&#xD;
&#xD;
      In this study, subjects with type 2 diabetes mellitus in combination with oral medication&#xD;
      will be treated with basic insulin to reduce fasting blood glucose, or with beinaglutide to&#xD;
      reduce postprandial blood glucose, in order to find out which one of controling blood glucose&#xD;
      can be more effective and observe the change of blood fluctuation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>The proportion and rate of the fasting blood glucose control.</measure>
    <time_frame>Baseline and week 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with glycosylated hemoglobin &lt; 7%.</measure>
    <time_frame>Baseline and week 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of blood sugar variation .</measure>
    <time_frame>Baseline and week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change percentage of glycosylated hemoglobin</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of blood glucose</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of blood pressure</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of blood lipids</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of body weight report in kilograms</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of body mass index report in kg/m^2</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-hip ration change</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative Stress Indice (8-Iso-PGF2α) change</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory factors (MCP-1) change</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory factors (hs-CRP) change</measure>
    <time_frame>Baseline and week16</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety Outcome Measure: Adverse Event</measure>
    <time_frame>From baseline to week 16</time_frame>
    <description>Adverse Event</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Outcome Measure: Serious adverse event</measure>
    <time_frame>From baseline to week 16</time_frame>
    <description>Serious adverse event</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Beinaglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beinaglutide for 8 weeks,&#xD;
Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glargine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glargine for 8 weeks,&#xD;
Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beinaglutide</intervention_name>
    <description>Beinaglutide for 8 weeks,&#xD;
Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )</description>
    <arm_group_label>Beinaglutide</arm_group_label>
    <arm_group_label>glargine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glargine</intervention_name>
    <description>Glargine for 8 weeks,&#xD;
Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )</description>
    <arm_group_label>Beinaglutide</arm_group_label>
    <arm_group_label>glargine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities&#xD;
&#xD;
          -  Male or female between the age of 18 and 70 years by the time of visit 1&#xD;
&#xD;
          -  Have been diagnosed as type 2 diabetes for at least half a year&#xD;
&#xD;
          -  Prestudy combination OAD therapy for at least 1 month(except glinides, DPP-VI&#xD;
             inhibitor,insulin,GLP-1 receptor agonists ),&#xD;
&#xD;
          -  The dose of Sulfonylureas less than the half maximum dose of insert&#xD;
&#xD;
          -  7.5%≤HbA1c≤11.0% in recent 2 weeks or on visit 1(local lab test)&#xD;
&#xD;
          -  21Kg/m2≤BMI≤35Kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females of child bearing potential who are pregnant, breast-feeding or intend to&#xD;
             become pregnant or are not using adequate contraceptive methods .&#xD;
&#xD;
          -  Current diagnosis or history of following:&#xD;
&#xD;
               -  Type 1 diabetes&#xD;
&#xD;
               -  Diabetes caused by impaired pancreas&#xD;
&#xD;
               -  Diabetes is the secondary diagnosis ,such as acromegaly,Cushing syndrome etc.&#xD;
&#xD;
               -  Acute decompensation of glycaemic control requiring immediate intensification of&#xD;
                  treatment to prevent acute complications of diabetes (eg. diabetes ketoacidosis,&#xD;
                  hyperosmolar coma) within 6months prior to screening.&#xD;
&#xD;
               -  Use of any glinides, DPP-VI inhibitor,GLP-1 receptor agonists within 3months&#xD;
                  prior to screening.Use of any insulin within 1months prior to screening.&#xD;
&#xD;
               -  History of allergy (such as systemic allergy, Vascular neuroedema, epidermal&#xD;
                  exfoliation, etc.)&#xD;
&#xD;
               -  Systemic use of glucocorticoids (oral or intravenous) continued for more than&#xD;
                  seven days in the past half year.&#xD;
&#xD;
               -  Triglyceride (fasting)&gt; 4.5mmol/L at visit 1.&#xD;
&#xD;
          -  Impaired liver function,such as manifested in one of the following situations:&#xD;
&#xD;
               -  Two consecutive measurements of AST or ALT in the first four weeks of the visit&#xD;
                  exceeded the maximum normal value by more than three times (local laboratory&#xD;
                  data)&#xD;
&#xD;
               -  Bilirubin synthesis and/or excretion disorders (such as hyperbilirubinemia) and&#xD;
                  other decompensated liver diseases such as coagulation,Blood disorders, hepatic&#xD;
                  encephalopathy, hypoproteinemia, ascites, esophageal variceal bleeding&#xD;
&#xD;
               -  Acute viral, active autoimmune, alcoholic and other types of hepatitis&#xD;
&#xD;
          -  Moderate to severe renal impairment or end-stage renal disease (estimated kidney) at&#xD;
             visit or 4 weeks before visit (local data)Globular filtration rate &lt; 60 mL/minNew York&#xD;
             Heart Association (NYHA) Class III or IV congestive heart failure&#xD;
&#xD;
          -  Visit 1 has a major history of cardiovascular disease in the past three months,&#xD;
             defined as myocardial infarction, coronary angioplasty or bypass surgery, valvular&#xD;
             disease or repair, unstable angina, transient ischemic attack or cerebrovascular&#xD;
             accident.&#xD;
&#xD;
          -  History of acute or chronic pancreatitis&#xD;
&#xD;
          -  History of gastrointestinal diseases, including gastrointestinal stoma anastomosis,&#xD;
             intestinal resection, gastric cardiac syndrome, severe hernia, intestinal obstruction,&#xD;
             intestinal ulcer&#xD;
&#xD;
          -  Malignant tumors (except cutaneous basal cell carcinoma, cervical carcinoma in situ&#xD;
             and prostate cancer in situ) have been diagnosed in the past five years.&#xD;
&#xD;
          -  History of organ transplantation or AIDS&#xD;
&#xD;
          -  History of medullary thyroid cancer&#xD;
&#xD;
          -  History of alcohol or drug abuse in the past 12 months&#xD;
&#xD;
          -  Individuals or researchers who do not comply with the potential risks of the program&#xD;
             are judged to be unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chang'an Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>China,Shanxi</state>
        <zip>710016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaanxi Aerospace Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>China,Shanxi</state>
        <zip>710025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 16, 2022</last_update_submitted>
  <last_update_submitted_qc>January 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <keyword>Beinaglutide</keyword>
  <keyword>glycemic variability</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03829891
org study id: KY20182008-1
nct id: NCT03829891
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to assess the efficacy and safety of Beinaglutide versus glargine ,
      in individuals with type 2 diabetes who did not achieve adequate glycaemic control with oral
      antidiabetic drug.
The investigators wonder in clinical hypoglycemic treatment for patients with hyperglycemia,
      whether to reduce fasting blood glucose or postprandial blood glucose first.

      In this study, subjects with type 2 diabetes mellitus in combination with oral medication
      will be treated with basic insulin to reduce fasting blood glucose, or with beinaglutide to
      reduce postprandial blood glucose, in order to find out which one of controling blood glucose
      can be more effective and observe the change of blood fluctuation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion and rate of the fasting blood glucose control.
time frame: Baseline and week 16
measure: Proportion of patients with glycosylated hemoglobin < 7%.
time frame: Baseline and week 16
measure: Changes of blood sugar variation .
time frame: Baseline and week 16
measure: Change percentage of glycosylated hemoglobin
time frame: Baseline and week16
measure: Change of blood glucose
time frame: Baseline and week16
measure: Change of blood pressure
time frame: Baseline and week16
measure: Change of blood lipids
time frame: Baseline and week16
measure: Change of body weight report in kilograms
time frame: Baseline and week16
measure: Change of body mass index report in kg/m^2
time frame: Baseline and week16
measure: Waist-hip ration change
time frame: Baseline and week16
measure: Oxidative Stress Indice (8-Iso-PGF2α) change
time frame: Baseline and week16
measure: Inflammatory factors (MCP-1) change
time frame: Baseline and week16
measure: Inflammatory factors (hs-CRP) change
time frame: Baseline and week16
measure: Safety Outcome Measure: Adverse Event
time frame: From baseline to week 16
description: Adverse Event
measure: Safety Outcome Measure: Serious adverse event
time frame: From baseline to week 16
description: Serious adverse event
arm group label: Beinaglutide
arm group type: Experimental
description: Beinaglutide for 8 weeks,
Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )
arm group label: glargine
arm group type: Active Comparator
description: Glargine for 8 weeks,
Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
intervention type: Drug
intervention name: Beinaglutide
description: Beinaglutide for 8 weeks,
Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )
arm group label: Beinaglutide
arm group label: glargine
intervention type: Drug
intervention name: glargine
description: Glargine for 8 weeks,
Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )
arm group label: Beinaglutide
arm group label: glargine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin Glargine