<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/NCT03230786</url>
  </required_header>
  <id_info>
    <org_study_id>KBP042/CD/003</org_study_id>
    <secondary_id>2017-001061-24</secondary_id>
    <nct_id>NCT03230786</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes</brief_title>
  <official_title>A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KeyBioscience AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nordic Bioscience A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>KeyBioscience AG</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>
      This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II&#xD;
      trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type&#xD;
      2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of&#xD;
      metformin.&#xD;
&#xD;
      The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and&#xD;
      United Kingdom&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 9, 2018</primary_completion_date>
  <phase>Phase 2</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in blood HbA1c at 12 weeks versus placebo.</measure>
    <time_frame>At 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in body weight at 12 weeks versus placebo.</measure>
    <time_frame>At 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting serum glucose at 12 weeks versus placebo</measure>
    <time_frame>At 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting serum insulin at 12 weeks versus placebo</measure>
    <time_frame>At 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting serum glucagon at 12 weeks versus placebo</measure>
    <time_frame>At 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo</measure>
    <time_frame>At 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">255</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo QD for 12 weeks as add-on to metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15µg KBP-042 QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30µg KBP-042 QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50µg KBP-042 QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daily injection of KBP/placebo for 12 weeks as add-on to metformin</intervention_name>
    <description>Daily subcutaneous injection</description>
    <arm_group_label>15µg KBP-042 QD</arm_group_label>
    <arm_group_label>30µg KBP-042 QD</arm_group_label>
    <arm_group_label>50µg KBP-042 QD</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects, 18-75 years of age, both inclusive, at the time of the first&#xD;
             screening visit. Women must be either using adequate, highly effective methods of&#xD;
             contraception, be post-menopausal or be considered sterile due to tubal ligation or&#xD;
             other surgical procedures at the time of randomization. Sexually active men with a&#xD;
             female partner of childbearing potential must agree in the use of highly effective&#xD;
             method of contraception by the female partner throughout the trial period.&#xD;
&#xD;
          2. Subjects with type 2 diabetes mellitus diagnosis whose HbA1c levels are ≥7.0% and&#xD;
             ≤10.0% (53 mmol/mol to 86 mmol/mol, respectively) at screening.&#xD;
&#xD;
          3. Stable therapy (for at least 90 days prior to randomization) with metformin.&#xD;
&#xD;
          4. Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².&#xD;
&#xD;
          5. The subject is able to understand and comply with protocol requirements.&#xD;
&#xD;
          6. The subject is able and willing to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Investigator considering the subject inappropriate for inclusion in the study based on&#xD;
             medical interview and/or physical examination.&#xD;
&#xD;
          2. Past or present significant co-morbidity (other than type 2 diabetes mellitus)&#xD;
             including, but not limited to: Active liver disease (other than asymptomatic&#xD;
             non-alcoholic fatty liver disease), significant renal disease (including creatinine&#xD;
             clearance &lt; 45 ml/min by the Modification of Diet in Renal Disease (MDRD) method,&#xD;
             congestive heart failure (NYHA class III or IV), myocardial infarction within the past&#xD;
             12 months, unstable angina pectoris.&#xD;
&#xD;
          3. Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists&#xD;
             (DACRAs).&#xD;
&#xD;
          4. Currently receiving medical treatment for obesity.&#xD;
&#xD;
          5. History of bariatric surgery.&#xD;
&#xD;
          6. Current alcohol abuse.&#xD;
&#xD;
          7. Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors,&#xD;
             DPP4-inhibitors (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1)&#xD;
             analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.&#xD;
&#xD;
          8. Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days&#xD;
             of randomization.&#xD;
&#xD;
          9. Regular use of insulin or insulin analogues.&#xD;
&#xD;
         10. History or presence of sensitivity or allergy to the study drug or drugs, to their&#xD;
             components, or drugs of these classes or a history of drug or other allergy that&#xD;
             contraindicates participation.&#xD;
&#xD;
         11. History of sarcoma or other malignancy within the past five years, except adequately&#xD;
             treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia&#xD;
             or carcinoma in situ.&#xD;
&#xD;
         12. Participation in a study trial with any investigational new drug (new chemical entity)&#xD;
             within 90 days prior to the start of the study.&#xD;
&#xD;
         13. Pregnant females as determined by positive serum or urine human chorionic gonadotropin&#xD;
             (hCG) test at screening or prior to randomization or during the treatment phase of the&#xD;
             trial.&#xD;
&#xD;
         14. Breast-feeding women.&#xD;
&#xD;
         15. Known positive test results for hepatitis C antibodies, hepatitis B surface antigen,&#xD;
             and HIV at screening.&#xD;
&#xD;
         16. ALT (alanine transaminase) or AST (aspartat transaminase) &gt; 2.5 times the upper limit&#xD;
             of normal at screening or other clinically significant liver function test&#xD;
             abnormalities.&#xD;
&#xD;
         17. Clinically significant ECG abnormalities, as judged by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vdoviak Miroslav MUDr. - Interní Ambulance</name>
      <address>
        <city>Karlovy Vary</city>
        <zip>360 17</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital</name>
      <address>
        <city>Prague 2</city>
        <zip>128 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Clinical and experimental Medicine</name>
      <address>
        <city>Praha 4</city>
        <zip>140 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interní a Diabetologická ambulance, Clintrial s.r.o</name>
      <address>
        <city>Praha</city>
        <zip>100 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endokrinologicky Ústav</name>
      <address>
        <city>Praha</city>
        <zip>113 94</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabet2 s.r.o</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interní a Diabetologická ambulance</name>
      <address>
        <city>Uherské Hradiště</city>
        <zip>68 601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologická a Obezitologická ambulance</name>
      <address>
        <city>České Budějovice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital, Endokrinologisk Afdeling</name>
      <address>
        <city>Bispebjerg</city>
        <state>Copenhagen NV</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica</name>
      <address>
        <city>Ballerup</city>
        <state>Copenhagen</state>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica</name>
      <address>
        <city>Aalborg</city>
        <state>Jutland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital, Endocrinlogy Department</name>
      <address>
        <city>Aarhus</city>
        <state>Jutland</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjysk Sygehus</name>
      <address>
        <city>Esbjerg</city>
        <state>Jutland</state>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica</name>
      <address>
        <city>Vejle</city>
        <state>Jutland</state>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holbæk Sygehus</name>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rtl Sm Srl/Scr</name>
      <address>
        <city>Chisinau</city>
        <zip>MD2025</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rtl Sm Srl</name>
      <address>
        <city>Chisinau</city>
        <zip>MD2025</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badań Klinicznych PI-House sp. z o.o.</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczna Praktyka Lekarska Piotr Kubalski</name>
      <address>
        <city>Grudziądz</city>
        <zip>86-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno</name>
      <address>
        <city>Kraków</city>
        <zip>31-261</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)</name>
      <address>
        <city>Opole</city>
        <zip>45-367</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Hygea</name>
      <address>
        <city>Tychy</city>
        <zip>43-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne AMED</name>
      <address>
        <city>Warsaw</city>
        <zip>01-518</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer</name>
      <address>
        <city>Łódź</city>
        <zip>90-074</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Policlinica CCBR S.R.L.</name>
      <address>
        <city>Bucharest</city>
        <zip>030463</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutului Național de Diabet, Nutriție și Boli Metabolice &quot;Prof.Dr. N.C. Paulescu&quot;</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Nicodiab S.R.L.</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Sfinx Medica S.R.L.</name>
      <address>
        <city>Constanţa</city>
        <zip>900412</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Mediab S.R.L.</name>
      <address>
        <city>Targu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Mediab S.R.L.</name>
      <address>
        <city>Târgu-Mureş</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Pancras</name>
      <address>
        <city>London</city>
        <zip>WC1X 8QD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Moldova, Republic of</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 10, 2018</last_update_submitted>
  <last_update_submitted_qc>September 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <keyword>KBP-042</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>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not to be shared</ipd_description>
  </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/NCT03230786
org study id: KBP042/CD/003
secondary id: 2017-001061-24
nct id: NCT03230786
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II
      trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type
      2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of
      metformin.

      The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and
      United Kingdom
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in blood HbA1c at 12 weeks versus placebo.
time frame: At 12 weeks
measure: Change from baseline in body weight at 12 weeks versus placebo.
time frame: At 12 weeks
measure: Change from baseline in fasting serum glucose at 12 weeks versus placebo
time frame: At 12 weeks
measure: Change from baseline in fasting serum insulin at 12 weeks versus placebo
time frame: At 12 weeks
measure: Change from baseline in fasting serum glucagon at 12 weeks versus placebo
time frame: At 12 weeks
measure: Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo
time frame: At 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo QD for 12 weeks as add-on to metformin
arm group label: 15µg KBP-042 QD
arm group type: Experimental
description: Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin
arm group label: 30µg KBP-042 QD
arm group type: Experimental
description: Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin
arm group label: 50µg KBP-042 QD
arm group type: Experimental
description: Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin
intervention type: Drug
intervention name: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
description: Daily subcutaneous injection
arm group label: 15µg KBP-042 QD
arm group label: 30µg KBP-042 QD
arm group label: 50µg KBP-042 QD
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Czechia
country: Denmark
country: Moldova, Republic of
country: Poland
country: Romania
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
sharing ipd: No
ipd description: Not to be shared