<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/NCT03033433</url>
  </required_header>
  <id_info>
    <org_study_id>DCB-DM101-CP001</org_study_id>
    <nct_id>NCT03033433</nct_id>
  </id_info>
  <brief_title>DCB-DM101 in Healthy Volunteers and for Type 2 Diabetes Mellitus Patients</brief_title>
  <official_title>An Open-label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VitNovo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VitNovo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating&#xD;
      Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in&#xD;
      Type 2 Diabetes Mellitus (T2DM) Patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, open-label, phase-I study consisting of two stages: Stage 1 will be&#xD;
      dose-escalation study to assess the safety and tolerability profile of three escalating doses&#xD;
      of DCB-DM101 in healthy volunteers and Stage 2 will apply optimum dose of DCB-DM101 as add-on&#xD;
      treatment in T2DM patients. In Stage 2, patients are allowed to receive metformin for T2DM&#xD;
      for routine use of which the dosing regimen should not be adjusted. No other&#xD;
      medication/treatments for T2DM are allowed. Stage 2 can only be proceeded upon the approval&#xD;
      of health authority in Taiwan. After determining the optimal dose for Stage 2, the reasons&#xD;
      for determining such dose together with relevant supporting data should be submitted to&#xD;
      health authority in Taiwan for review and to determine whether stage 2 can be proceeded and&#xD;
      which dose should be employed for stage 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 1</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>
    <masking_description>open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT)</measure>
    <time_frame>7 months</time_frame>
    <description>Primary endpoint, DLT is defined as: Any causally related adverse event as judged by investigator is greater than or equal to Grade 2. The causality of each adverse event to investigational product will be judged by investigator during the conduction of each dosing cohort in Stage I. DSMB will reevaluate the causality of each DLT after the completion or termination of this dosing cohort judged by investigator to determine whether dose escalation or entering to stage 2 can be proceeded.Optimal Dose will be one tablet or two tablets or 4 tablets. the optimal dose for stage 2 is defined using rules as follows but will be determined by sponsor and investigators.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2: Number of Participants with Adverse events and Serious adverse events that are related to treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Specified:Primary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.&#xD;
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage1: Number of Participants with Adverse events and Serious adverse events that are related to treatment</measure>
    <time_frame>7 months</time_frame>
    <description>Secondary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.&#xD;
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage2: Change from baseline in results of oral glucose tolerance test (OGTT)</measure>
    <time_frame>0 (pre-dose) and 0.5, 1, 1.5, 2, 2.5 hours post-dose</time_frame>
    <description>While patient takes OGTT at Screening visit, blood glucose will be monitor at right before, 0.5, 1, 1.5, and 2 hr after administration of solution containing 75 g glucose. While at visit 2 and 4, blood glucose will be monitored at pre-dose, right before taking solution containing 75 g glucose(30 mins after dosing), 1, 1.5, 2, and 2.5 hr after administration of dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage2: Change from baseline in biomarker( serum insulin) testing results.</measure>
    <time_frame>Visits 1 (-30 to 1 days), Visit 2 (Day 1), Visits 3 (Day 8), Visit 4(Day 14)and 5 (Day 28).</time_frame>
    <description>Biomarker consists of serum insulin. Insulin will be measured at all the same time points where blood glucose is measured including OGTT test time points for Visits 1 (-30 to 1 days), 2 (Day 1), and 4(Day 14), and single blood sampling besides laboratory test for Visits 3 (Day 8) and 5 (Day 28).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage2: Change from baseline in biomarker( serum fructosamine) testing results.</measure>
    <time_frame>Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).</time_frame>
    <description>Fructosamine at will be measured at Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>DCB-DM101, 500 mg tablet, determination of optimal dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stage 1:Dose level 1(1 tablet of DCB-DM101 q.d. for 7 days orally);Dose level 2(2 tablets of DCB-DM101 q.d. for 7 days orally);Dose level 3(4 tablets of DCB-DM101 q.d. for 7 days orally) Stage 2:Optimum dose of DCB-DM101 determined in Stage 1 as add-on treatment in T2DM patients for 14 days, q.d., orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DCB-DM101</intervention_name>
    <description>determination of optimal dose for Stage 2</description>
    <arm_group_label>DCB-DM101, 500 mg tablet, determination of optimal dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Stage 1&#xD;
&#xD;
          1. Adult, male or female aged between 20-40 years old;&#xD;
&#xD;
          2. Physically and mentally healthy subjects as confirmed by an interview, medical&#xD;
             history, clinical examination, chest X-rays, and electrocardiogram;&#xD;
&#xD;
          3. Body Mass Index (BMI) between 18.5 and 24, inclusive, (BMI will be calculated as&#xD;
             weight in kilogram [kg]/height in meters2 [m2]);&#xD;
&#xD;
          4. Clinically normal hematology, biochemistry and urinalysis determinations based on&#xD;
             investigator's discretion;&#xD;
&#xD;
          5. Subject is willing and able to comply with study procedures and sign informed consent.&#xD;
&#xD;
        Stage 2&#xD;
&#xD;
          1. Male or female aged between 20-70 years old;&#xD;
&#xD;
          2. Diagnosed T2DM (WHO 1999 criteria);&#xD;
&#xD;
          3. Not effective in alleviating T2DM after monotherapy of metformin 1,500mg/day [or&#xD;
             1,000mg/day if unable to tolerate higher dose] for 3 months&#xD;
&#xD;
          4. HbA1c of 7.0 % to 9.0% (inclusive);&#xD;
&#xD;
          5. BMI of at most 35 kg/m2;&#xD;
&#xD;
          6. Subject is willing and able to comply with study procedures and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Stage 1&#xD;
&#xD;
          1. Subjects who have a history or evidence of a medical condition that would expose them&#xD;
             to an undue risk of a significant adverse event or interfere with the assessments of&#xD;
             safety or pharmacodynamics variables during the course of the trial, including but not&#xD;
             limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune,&#xD;
             neurological, musculoskeletal or hematological disease as determined by the clinical&#xD;
             judgment of the investigator;&#xD;
&#xD;
          2. Subject has received any investigational agent within 28 days or 5 half-lives,&#xD;
             whichever is longer, prior to the first dose of study drug;&#xD;
&#xD;
          3. Subjects have taken or potentially take any prescription medication and/or over&#xD;
             the-counter medication from within 1 week prior to the first dose of study drug to the&#xD;
             end of study period;&#xD;
&#xD;
          4. Subject has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24&#xD;
             hours prior to the administration of study drug;&#xD;
&#xD;
          5. Female subject of childbearing potential who: is lactating; or has positive urine&#xD;
             pregnancy test at Visit 1; or refuses to adopt at least two forms of birth control (at&#xD;
             least one of which must be a barrier method) during the study.&#xD;
&#xD;
        Stage 2&#xD;
&#xD;
          1. Known or suspected allergy to any ingredients of study product&#xD;
&#xD;
          2. Pregnant or lactating or premenopausal with childbearing potential but not taking at&#xD;
             least two forms of birth control (at least one of which must be a barrier method)&#xD;
             during the study.&#xD;
&#xD;
        Note: Acceptable forms include:&#xD;
&#xD;
          1. Established use of oral, injected or implanted hormonal methods of contraception.&#xD;
&#xD;
          2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).&#xD;
&#xD;
          3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault&#xD;
             caps) with spermicidal foam/gel/film/cream/suppository. 3. Participated in another&#xD;
             clinical trial and received an investigational drug within four weeks prior to the&#xD;
             present trial&#xD;
&#xD;
          4. Impaired hepatic function defined as alanine aminotransferase (ALT), aspartate&#xD;
             transaminase (AST) or alkaline phosphatase (ALP) at least 2.5 times upper referenced&#xD;
             limit&#xD;
&#xD;
          5. Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115&#xD;
             umol/L) for males and at least 1.2 mg/dL (at least 106 umol/L) for females&#xD;
&#xD;
          6. With any uncontrolled illness or a history of any illness judged by the investigator&#xD;
             that entering the trial may be detrimental to the subject&#xD;
&#xD;
          7. Metformin contraindications according to the package insert&#xD;
&#xD;
          8. Current treatment with systemic corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Jen Hung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-Service General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>No</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/NCT03033433
org study id: DCB-DM101-CP001
nct id: NCT03033433
lead sponsor: 
has dmc: Yes
An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating
      Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in
      Type 2 Diabetes Mellitus (T2DM) Patients
This is a single center, open-label, phase-I study consisting of two stages: Stage 1 will be
      dose-escalation study to assess the safety and tolerability profile of three escalating doses
      of DCB-DM101 in healthy volunteers and Stage 2 will apply optimum dose of DCB-DM101 as add-on
      treatment in T2DM patients. In Stage 2, patients are allowed to receive metformin for T2DM
      for routine use of which the dosing regimen should not be adjusted. No other
      medication/treatments for T2DM are allowed. Stage 2 can only be proceeded upon the approval
      of health authority in Taiwan. After determining the optimal dose for Stage 2, the reasons
      for determining such dose together with relevant supporting data should be submitted to
      health authority in Taiwan for review and to determine whether stage 2 can be proceeded and
      which dose should be employed for stage 2.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: open label
measure: Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT)
time frame: 7 months
description: Primary endpoint, DLT is defined as: Any causally related adverse event as judged by investigator is greater than or equal to Grade 2. The causality of each adverse event to investigational product will be judged by investigator during the conduction of each dosing cohort in Stage I. DSMB will reevaluate the causality of each DLT after the completion or termination of this dosing cohort judged by investigator to determine whether dose escalation or entering to stage 2 can be proceeded.Optimal Dose will be one tablet or two tablets or 4 tablets. the optimal dose for stage 2 is defined using rules as follows but will be determined by sponsor and investigators.
measure: Stage 2: Number of Participants with Adverse events and Serious adverse events that are related to treatment
time frame: 3 months
description: Specified:Primary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.
measure: Stage1: Number of Participants with Adverse events and Serious adverse events that are related to treatment
time frame: 7 months
description: Secondary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.
measure: Stage2: Change from baseline in results of oral glucose tolerance test (OGTT)
time frame: 0 (pre-dose) and 0.5, 1, 1.5, 2, 2.5 hours post-dose
description: While patient takes OGTT at Screening visit, blood glucose will be monitor at right before, 0.5, 1, 1.5, and 2 hr after administration of solution containing 75 g glucose. While at visit 2 and 4, blood glucose will be monitored at pre-dose, right before taking solution containing 75 g glucose(30 mins after dosing), 1, 1.5, 2, and 2.5 hr after administration of dose.
measure: Stage2: Change from baseline in biomarker( serum insulin) testing results.
time frame: Visits 1 (-30 to 1 days), Visit 2 (Day 1), Visits 3 (Day 8), Visit 4(Day 14)and 5 (Day 28).
description: Biomarker consists of serum insulin. Insulin will be measured at all the same time points where blood glucose is measured including OGTT test time points for Visits 1 (-30 to 1 days), 2 (Day 1), and 4(Day 14), and single blood sampling besides laboratory test for Visits 3 (Day 8) and 5 (Day 28).
measure: Stage2: Change from baseline in biomarker( serum fructosamine) testing results.
time frame: Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).
description: Fructosamine at will be measured at Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).
arm group label: DCB-DM101, 500 mg tablet, determination of optimal dose
arm group type: Experimental
description: Stage 1:Dose level 1(1 tablet of DCB-DM101 q.d. for 7 days orally);Dose level 2(2 tablets of DCB-DM101 q.d. for 7 days orally);Dose level 3(4 tablets of DCB-DM101 q.d. for 7 days orally) Stage 2:Optimum dose of DCB-DM101 determined in Stage 1 as add-on treatment in T2DM patients for 14 days, q.d., orally
intervention type: Drug
intervention name: DCB-DM101
description: determination of optimal dose for Stage 2
arm group label: DCB-DM101, 500 mg tablet, determination of optimal dose
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yi-Jen Hung, MD
role: Principal Investigator
affiliation: Tri-Service General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No