<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/NCT01703637</url>
  </required_header>
  <id_info>
    <org_study_id>qfsnfm-001</org_study_id>
    <nct_id>NCT01703637</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Comparative Study of Sitagliptin,Vildagliptin and Saxagliptin</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind Comparative Study of Efficacy，Tolerance and Safety Between Sitagliptin ,Vildagliptin and Saxagliptin After 12-week Monotherapy in Drug-naive Adult Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lin Liao</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>
      The purpose of this study is to explore the differences in efficacy and safety of&#xD;
      sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating&#xD;
      type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">December 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour Postprandial Glucose at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Insulin at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Glucagon at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour Postprandial Insulin at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2-hour Postprandial Glucagon at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in abdominal perimeter at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Lipids at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Patients Achieving A1C &lt; 7% and Achieving A1C&lt;6.5% at Week12</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The side effect of each drug.</measure>
    <time_frame>Baseline to week 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>gene polymorphism study</measure>
    <time_frame>baseline and week 12</time_frame>
    <description>We will choose 6 mutation types of CYP3A4 common in Chinese,and make blood medicinal concentration assay of participants with these gene types,and then analyse the association between different gene types and the change of glucose level or HbA1c or rate of adverse event.</description>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline in content of NOS</measure>
    <time_frame>baseline and week 12</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sitagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vildagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saxagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sitagliptin</intervention_name>
    <description>before breakfast：a tablet of sitagliptin; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy&#xD;
before dinner：a tablet of sitagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy</description>
    <arm_group_label>Sitagliptin</arm_group_label>
    <other_name>Januvia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin</intervention_name>
    <description>before breakfast：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy&#xD;
before dinner：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy</description>
    <arm_group_label>Vildagliptin</arm_group_label>
    <other_name>Galvus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saxagliptin</intervention_name>
    <description>before breakfast：a tablet of saxagliptin; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy&#xD;
before dinner：a tablet of saxagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy</description>
    <arm_group_label>Saxagliptin</arm_group_label>
    <other_name>Onglyza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed the informed consent&#xD;
&#xD;
          -  diagnosed with T2DM&#xD;
&#xD;
          -  women of childbearing potential were required to have a negative urine; pregnancy&#xD;
             test,and agreed to use adequate contraception throughout the; study and for up to 4&#xD;
             weeks after completion&#xD;
&#xD;
          -  glycosylated hemoglobin ranged in 6.5-9.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients in pregnancy or lactation period&#xD;
&#xD;
          -  ever received any kind of oral Hypoglycemic drug in recent 3 months&#xD;
&#xD;
          -  patients were currently receiving treatment with a cytochrome P450 3A4 inducer or&#xD;
             depressor,a systemic corticosteroid,or a human immunodeficiency virus anti-viral&#xD;
             medication&#xD;
&#xD;
          -  gastrointestinal surgery that could affect drug absorption&#xD;
&#xD;
          -  patients with haemoglobinopathy or rapidly progressing renal disease, or autoimmune&#xD;
             skin disorder&#xD;
&#xD;
          -  a recent history of alcohol or drug abuse within the past 12 months&#xD;
&#xD;
          -  any contraindication listed in the package inserts of the study drugs&#xD;
&#xD;
          -  a history of acute or chronic Pancreatitis or currently&#xD;
&#xD;
          -  type 1 diabetes; a history of diabetic ketoacidosis or hyperosmolar nonketonic coma&#xD;
&#xD;
          -  New York Heart Association class III or IV congestive heart failure; left ventricular&#xD;
             ejection fraction ≤ 40%; a major cardiovascular event within the past 6 months&#xD;
&#xD;
          -  significant abnormal liver function, defined as aspartate aminotransferase or alanine&#xD;
             aminotransferase &gt; 2 times the upper limit of normal or total bilirubin &gt;34 µmol/L (&gt;&#xD;
             2 mg/dL); or a history of positive serologic evidence of infectious liver disease&#xD;
&#xD;
          -  clinical signs or symptoms of active liver disease and/or significant abnormal liver&#xD;
             function&#xD;
&#xD;
          -  patients with any clinically significant abnormality identified on physical&#xD;
             examination, electrocardiogram (ECG), or laboratory tests that, in the judgment of the&#xD;
             investigator, would compromise the patients' safety or successful participation in the&#xD;
             clinical study&#xD;
&#xD;
          -  fasting plasma glucose level &gt; 13.3mmol/l&#xD;
&#xD;
          -  creatinine clearance rate ≤ 90ml/min&#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>
  <overall_contact>
    <last_name>Lin Liao, MD</last_name>
    <phone>8615168888260</phone>
    <email>liaolin@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>YuCheng people's hospital</name>
      <address>
        <city>Dezhou</city>
        <state>Shandong</state>
        <zip>253000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pengfei Li</last_name>
      <email>lpf9669@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of SINOTRUK</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiling Fu</last_name>
      <email>fxl1936@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinan central hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuguang Pang</last_name>
      <email>shuguangpang@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The jinan military region general hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaoshun Jiang</last_name>
      <email>zhaoshunjiang@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qianfoshan Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Liao, MD</last_name>
      <phone>8615168888260</phone>
      <email>liaolin@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Qingdao Chengyang</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaopang Rao</last_name>
      <email>123raoxiaopang@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zibo central hospital</name>
      <address>
        <city>Zibo</city>
        <state>Shandong</state>
        <zip>255000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaodong Zhao</last_name>
      <email>19xiaodong@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zibo eighth people's hospital</name>
      <address>
        <city>Zibo</city>
        <state>Shandong</state>
        <zip>255000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ling Dai</last_name>
      <phone>+86 13853388549</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Sitagliptin</keyword>
  <keyword>Vildagliptin</keyword>
  <keyword>Saxagliptin</keyword>
  <keyword>Diabetes Mellitus, Type 2</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>Sitagliptin Phosphate</mesh_term>
    <mesh_term>Vildagliptin</mesh_term>
    <mesh_term>Saxagliptin</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/NCT01703637
org study id: qfsnfm-001
nct id: NCT01703637
lead sponsor: 
has dmc: Yes
The purpose of this study is to explore the differences in efficacy and safety of
      sitagliptin,vildagliptin and saxagliptin and to find which one is more better in treating
      type 2 diabetes mellitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 12
time frame: Baseline and Week 12
description: Change from baseline reflects the Week 12 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
time frame: Baseline to Week 12
measure: Change From Baseline in 2-hour Postprandial Glucose at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in Fasting Insulin at Week 12
time frame: Baseline to Week 12
measure: Change From Baseline in Fasting Glucagon at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in 2-hour Postprandial Insulin at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in 2-hour Postprandial Glucagon at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in abdominal perimeter at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in Body Weight at Week 12
time frame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Lipids at Week 12
time frame: Baseline and Week 12
description: fasting plasma lipid parameters including total cholesterol(TC), triglyceride(TG) and Low density lipoprotein(LDL)
measure: The Proportion of Patients Achieving A1C < 7% and Achieving A1C<6.5% at Week12
time frame: Baseline and Week 12
measure: The side effect of each drug.
time frame: Baseline to week 12
measure: gene polymorphism study
time frame: baseline and week 12
description: We will choose 6 mutation types of CYP3A4 common in Chinese,and make blood medicinal concentration assay of participants with these gene types,and then analyse the association between different gene types and the change of glucose level or HbA1c or rate of adverse event.
measure: change from baseline in content of NOS
time frame: baseline and week 12
arm group label: Sitagliptin
arm group type: Experimental
description: Drug: sitagliptin sitagliptin 100mg tablet by mouth , once daily for 12 weeks
arm group label: Vildagliptin
arm group type: Experimental
description: Drug: vildagliptin saxagliptin 50mg tablet by mouth , twice daily for 12 weeks
arm group label: Saxagliptin
arm group type: Experimental
description: Drug: saxagliptin saxagliptin 5mg tablet by mouth , once daily for 12 weeks
intervention type: Drug
intervention name: Sitagliptin
description: before breakfast：a tablet of sitagliptin; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
before dinner：a tablet of sitagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
arm group label: Sitagliptin
other name: Januvia
intervention type: Drug
intervention name: Vildagliptin
description: before breakfast：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
before dinner：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
arm group label: Vildagliptin
other name: Galvus
intervention type: Drug
intervention name: Saxagliptin
description: before breakfast：a tablet of saxagliptin; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
before dinner：a tablet of saxagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
arm group label: Saxagliptin
other name: Onglyza
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
last name: Lin Liao, MD
phone: 8615168888260
email: liaolin@medmail.com.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Qianfoshan Hospital
investigator full name: Lin Liao
investigator title: chief of endocrinology department at Qianfoshan Hospital
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Sitagliptin Phosphate
mesh term: Vildagliptin
mesh term: Saxagliptin