<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/NCT03030300</url>
  </required_header>
  <id_info>
    <org_study_id>qfsnfm-005</org_study_id>
    <nct_id>NCT03030300</nct_id>
  </id_info>
  <brief_title>Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qianfoshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in&#xD;
      newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to&#xD;
      the remission rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prolonged-remission rate</measure>
    <time_frame>5 years</time_frame>
    <description>hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>partial-remission rate</measure>
    <time_frame>5 years</time_frame>
    <description>hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Novolin 30R;Pioglitazone;Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Novolin 30R;Pioglitazone;Metformin</intervention_name>
    <description>Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued;&#xD;
Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin;&#xD;
Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.</description>
    <arm_group_label>Novolin 30R;Pioglitazone;Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed, insulin-naive type 2 diabetes outpatients&#xD;
&#xD;
          -  Diabetes duration less than 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Various acute complications&#xD;
&#xD;
          -  Hepatic transaminase &gt;2.5x normal reference value (glutamic-pyruvic&#xD;
             transminase&gt;100U/L, glutamic-oxalacetic transaminase &gt; 100U/L)&#xD;
&#xD;
          -  Abnormal renal functions (serum cretinine&gt;the normal reference value)&#xD;
&#xD;
          -  Cardiac insufficiency (America NYHA caediac function &gt;3)&#xD;
&#xD;
          -  Type 1 diabetes mellitus&#xD;
&#xD;
          -  Ongoing hormone therapy&#xD;
&#xD;
          -  Women in gestation and lactation&#xD;
&#xD;
          -  Patients with other endocrine disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Liao, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qianfoshan Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
    <investigator_full_name>Lin Liao</investigator_full_name>
    <investigator_title>chief of endocrinology department at Qianfoshan Hospital</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>remission</keyword>
  <keyword>short-term intensive insulin therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Pioglitazone</mesh_term>
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030300
org study id: qfsnfm-005
nct id: NCT03030300
lead sponsor: 
has dmc: Yes
To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in
      newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to
      the remission rate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: prolonged-remission rate
time frame: 5 years
description: hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.
measure: partial-remission rate
time frame: 5 years
description: hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.
arm group label: Novolin 30R;Pioglitazone;Metformin
arm group type: Experimental
description: Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).
intervention type: Drug
intervention name: Novolin 30R;Pioglitazone;Metformin
description: Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued;
Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin;
Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.
arm group label: Novolin 30R;Pioglitazone;Metformin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
last name: Lin Liao, MD
role: Study Chair
affiliation: Qianfoshan Hospital
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Qianfoshan Hospital
investigator full name: Lin Liao
investigator title: chief of endocrinology department at Qianfoshan Hospital
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Pioglitazone
mesh term: Insulin
sharing ipd: Undecided