<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/NCT01717911</url>
  </required_header>
  <id_info>
    <org_study_id>VGHIRB 201007016MB</org_study_id>
    <secondary_id>NSC-2314-B-075-014</secondary_id>
    <nct_id>NCT01717911</nct_id>
  </id_info>
  <brief_title>ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia</brief_title>
  <official_title>ß-Cell Function and Glycemic Control of Basal Insulin, Metformin or Sitagliptin in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We have found that a 6-month course of insulin therapy after a short-term intensive insulin&#xD;
      therapy could shorten the period of hyperglycemia to preserve ß-cell function and further&#xD;
      improve long-term glycemic control in recently diagnosed type 2 diabetes with severe&#xD;
      hyperglycemia (&gt;300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus&#xD;
      hypothesized that a 6-month course of basal insulin therapy could also help to preserve&#xD;
      ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300&#xD;
      mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin&#xD;
      therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the&#xD;
      diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with&#xD;
      better ß-cell function reservation. We skip a short-term intensive admission course of&#xD;
      insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe&#xD;
      hyperglycemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects&#xD;
      responsible for the development of hyperglycemia. There is a progressive deterioration in&#xD;
      ß-cell function and mass in type 2 diabetics. Optimal metabolic control, especially early&#xD;
      intensive glycemic control, plays a role in the prevention of progressive ß-cell dysfunction&#xD;
      and possibly destruction of the ß-cells with worsening of diabetes.&#xD;
&#xD;
      We have found that a 6-month course of insulin therapy after a short-term intensive insulin&#xD;
      therapy could shorten the period of hyperglycemia to preserve ß-cell function and further&#xD;
      improve long-term glycemic control in recently diagnosed type 2 diabetes with severe&#xD;
      hyperglycemia (&gt;300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus&#xD;
      hypothesized that a 6-month course of basal insulin therapy could also help to preserve&#xD;
      ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300&#xD;
      mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin&#xD;
      therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the&#xD;
      diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with&#xD;
      better ß-cell function reservation. We skip a short-term intensive admission course of&#xD;
      insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe&#xD;
      hyperglycemia.&#xD;
&#xD;
      This study also can assess what readily available parameter would predict which patients will&#xD;
      achieve long-term successful glycemic control after correction of glucose toxicity.&#xD;
&#xD;
      Our results will provide evidence that a 6-month course of basal insulin therapy could&#xD;
      shorten the exposure to moderate hyperglycemia and further improve beta-cell function to&#xD;
      achieve long-term glycemic control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2010</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome was the comparison of A1C change.</measure>
    <time_frame>Dec. 2013</time_frame>
    <description>The primary outcome was the comparison of A1C change.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function and insulin sensitivity and the proportion of subjects who reached the treatment target (A1C &lt;7.0% or &lt;6.5% at 6 months).</measure>
    <time_frame>Dec 2013</time_frame>
    <description>The secondary efficacy analysis was the beta-cell function and insulin sensitivity calculated from OGTT and the proportion of subjects who reached the treatment target (A1C &lt;7.0% or &lt;6.5% at 6 months).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was &lt;70mg /dl, discontinued the study if blood glucose was still &lt;70mg/dl under sitagliptin 50mg per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the insulin therapy group (Insulin glargine), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Daily dose was administrated before breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin</intervention_name>
    <description>In the insulin therapy group (Humulin-N), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Two third daily dose was administrated before breakfast and one third at bedtime. Insulin doses were titrated every 3 days to achieve target fasting plasma glucose values between 90 and 130 mg/dl.</description>
    <arm_group_label>Insulin</arm_group_label>
    <other_name>Humulin-N</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).</description>
    <arm_group_label>Metformin</arm_group_label>
    <other_name>Glucophage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was &lt;70mg /dl, discontinued the study if blood glucose was still &lt;70mg/dl under sitagliptin 50mg per day.</description>
    <arm_group_label>Sitagliptin</arm_group_label>
    <other_name>Januvia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Recently diagnosed type 2 diabetic patients.&#xD;
&#xD;
          2. Fasting plasma glucose between 200-300 mg/dl (A1C level between 7% and 10%).&#xD;
&#xD;
          3. Those who age between 30 and 80 years old and can inject insulin by themselves.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treated with anti-diabetic medication&#xD;
&#xD;
          2. Pregnant or nursing women.&#xD;
&#xD;
          3. Impaired liver function (ALT &gt; 120 U/L)&#xD;
&#xD;
          4. Impaired renal function (Serum creatinine &gt;1.5 mg/dL in male, &gt;1.4 mg/dL in female )&#xD;
&#xD;
          5. Recently suffered from MI or CVA.&#xD;
&#xD;
          6. Patients are acute intercurrent illness.&#xD;
&#xD;
          7. 2-hour C-peptide level &lt; 1.8 ng/mL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harn-Shen Chen, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Endocrinology and Metabolism</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harn-Shen Chen, MD, PhD</last_name>
      <phone>886-2-28757515</phone>
      <email>chenhs@vghtpe.gov.tw</email>
    </contact>
    <investigator>
      <last_name>Harn-Shen Chen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Chen HS, Wu TE, Jap TS, Hsiao LC, Lee SH, Lin HD. Beneficial effects of insulin on glycemic control and beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia after short-term intensive insulin therapy. Diabetes Care. 2008 Oct;31(10):1927-32. doi: 10.2337/dc08-0075. Epub 2008 Jun 12.</citation>
    <PMID>18556343</PMID>
  </reference>
  <verification_date>July 2010</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 28, 2012</last_update_submitted>
  <last_update_submitted_qc>October 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Division of Endocrinology and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Newly diagnosed type 2 diabetes</keyword>
  <keyword>Insulin, metformin, sitagliptin</keyword>
  <keyword>beta-cell function, glycemic control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Isophane Insulin, Human</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/NCT01717911
org study id: VGHIRB 201007016MB
secondary id: NSC-2314-B-075-014
nct id: NCT01717911
lead sponsor: 
has dmc: No
We have found that a 6-month course of insulin therapy after a short-term intensive insulin
      therapy could shorten the period of hyperglycemia to preserve ß-cell function and further
      improve long-term glycemic control in recently diagnosed type 2 diabetes with severe
      hyperglycemia (>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus
      hypothesized that a 6-month course of basal insulin therapy could also help to preserve
      ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300
      mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin
      therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the
      diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with
      better ß-cell function reservation. We skip a short-term intensive admission course of
      insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe
      hyperglycemia.
ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects
      responsible for the development of hyperglycemia. There is a progressive deterioration in
      ß-cell function and mass in type 2 diabetics. Optimal metabolic control, especially early
      intensive glycemic control, plays a role in the prevention of progressive ß-cell dysfunction
      and possibly destruction of the ß-cells with worsening of diabetes.

      We have found that a 6-month course of insulin therapy after a short-term intensive insulin
      therapy could shorten the period of hyperglycemia to preserve ß-cell function and further
      improve long-term glycemic control in recently diagnosed type 2 diabetes with severe
      hyperglycemia (>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus
      hypothesized that a 6-month course of basal insulin therapy could also help to preserve
      ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300
      mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin
      therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the
      diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with
      better ß-cell function reservation. We skip a short-term intensive admission course of
      insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe
      hyperglycemia.

      This study also can assess what readily available parameter would predict which patients will
      achieve long-term successful glycemic control after correction of glucose toxicity.

      Our results will provide evidence that a 6-month course of basal insulin therapy could
      shorten the exposure to moderate hyperglycemia and further improve beta-cell function to
      achieve long-term glycemic control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome was the comparison of A1C change.
time frame: Dec. 2013
description: The primary outcome was the comparison of A1C change.
measure: Beta-cell function and insulin sensitivity and the proportion of subjects who reached the treatment target (A1C <7.0% or <6.5% at 6 months).
time frame: Dec 2013
description: The secondary efficacy analysis was the beta-cell function and insulin sensitivity calculated from OGTT and the proportion of subjects who reached the treatment target (A1C <7.0% or <6.5% at 6 months).
arm group label: Metformin
arm group type: Active Comparator
description: The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).
arm group label: Sitagliptin
arm group type: Experimental
description: The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was <70mg /dl, discontinued the study if blood glucose was still <70mg/dl under sitagliptin 50mg per day.
arm group label: Insulin
arm group type: Experimental
description: In the insulin therapy group (Insulin glargine), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Daily dose was administrated before breakfast.
intervention type: Drug
intervention name: Insulin
description: In the insulin therapy group (Humulin-N), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Two third daily dose was administrated before breakfast and one third at bedtime. Insulin doses were titrated every 3 days to achieve target fasting plasma glucose values between 90 and 130 mg/dl.
arm group label: Insulin
other name: Humulin-N
intervention type: Drug
intervention name: Metformin
description: The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).
arm group label: Metformin
other name: Glucophage
intervention type: Drug
intervention name: Sitagliptin
description: The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was <70mg /dl, discontinued the study if blood glucose was still <70mg/dl under sitagliptin 50mg per day.
arm group label: Sitagliptin
other name: Januvia
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Harn-Shen Chen, MD, Phd
role: Principal Investigator
affiliation: Division of Endocrinology and Metabolism
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
citation: Chen HS, Wu TE, Jap TS, Hsiao LC, Lee SH, Lin HD. Beneficial effects of insulin on glycemic control and beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia after short-term intensive insulin therapy. Diabetes Care. 2008 Oct;31(10):1927-32. doi: 10.2337/dc08-0075. Epub 2008 Jun 12.
PMID: 18556343
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Division of Endocrinology and Metabolism
mesh term: Diabetes Mellitus, Type 2
mesh term: Hyperglycemia
mesh term: Metformin
mesh term: Sitagliptin Phosphate
mesh term: Isophane Insulin, Human