<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/NCT01664676</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1131-5236</org_study_id>
    <secondary_id>2012-003577-26</secondary_id>
    <nct_id>NCT01664676</nct_id>
  </id_info>
  <brief_title>Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients</brief_title>
  <official_title>A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against&#xD;
      diabetic nephropathy. We hypothesise that this is also the case in humans. This study will&#xD;
      investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2&#xD;
      diabetic patients. Impact on basic kidney physiological will be determined and kidney injury&#xD;
      markers will be measured as surrogate parameters of kidney protection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glomerular Filtration Rate (51Cr-EDTA plasma clearance)</measure>
    <time_frame>10-15 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal Blood Flow (functional magnetic resonance imaging)</measure>
    <time_frame>15 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal electrolyte clearance</measure>
    <time_frame>10-15 hours post-dose</time_frame>
    <description>Sodium, potassium, calcium, lithium and osmotically active substances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excretion of kidney injury markers</measure>
    <time_frame>0-10 hours and 10-15 hours post-dose</time_frame>
    <description>Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of various hormones</measure>
    <time_frame>10-15 hours post-dose</time_frame>
    <description>Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.2 mg liraglutide sc. (single-dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-liraglutide</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo liraglutide sc. (single-dose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <arm_group_label>Liraglutide</arm_group_label>
    <other_name>Victoza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-liraglutide</intervention_name>
    <arm_group_label>Placebo-liraglutide</arm_group_label>
    <other_name>Isotonic saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities.&#xD;
&#xD;
          -  Male gender&#xD;
&#xD;
          -  T2DM, diagnosed according to international guidelines&#xD;
&#xD;
          -  Age 20-60 years, both included&#xD;
&#xD;
          -  Body Mass Index (BMI): 20-32 kg/m2, both included&#xD;
&#xD;
          -  Metformin treatment&#xD;
&#xD;
          -  Albumin/creatinine ratio &lt;25 mg/mmol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected allergy to trial product or related products&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
&#xD;
          -  Previous treatment with GLP-1 analogues or DPP-4 inhibitors&#xD;
&#xD;
          -  Current treatment with any antidiabetic drug other than metformin&#xD;
&#xD;
          -  Poorly regulated glycemic control (HbA1c &gt; 8%)&#xD;
&#xD;
          -  Impaired kidney function: estimated GFR &lt; 70ml/min&#xD;
&#xD;
          -  Impaired liver function: liver parameters exceed 2 times upper normal limit&#xD;
&#xD;
          -  Subjects with active malignancy&#xD;
&#xD;
          -  Severe cardiac insufficiency classified according to NYHA III-IV&#xD;
&#xD;
          -  Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months&#xD;
&#xD;
          -  Severe, uncontrolled hypertension: sitting blood pressure (BP) &gt; 180/110 mmHg&#xD;
&#xD;
          -  Antihypertensive treatment consisting of more than two different pharmaceutical&#xD;
             products&#xD;
&#xD;
          -  Symptoms related to benign prostate hyperplasia&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Any metal body implants&#xD;
&#xD;
          -  History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine&#xD;
             neoplasia syndrome type 2&#xD;
&#xD;
          -  Personal or family history of medullary thyroid carcinoma&#xD;
&#xD;
          -  Any diseases judged by the investigator that could affect the trial&#xD;
&#xD;
          -  Any medication judged by the investigator that could affect the trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens S Christiansen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital, Department of Endocrinology and Diabetes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital, Department of Endocrinology and Diabetes</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>February 27, 2014</last_update_submitted>
  <last_update_submitted_qc>February 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liraglutide</keyword>
  <keyword>victoza</keyword>
  <keyword>GLP-1</keyword>
  <keyword>kidney</keyword>
  <keyword>diabetes</keyword>
  <keyword>renal</keyword>
  <keyword>diabetic nephropathy</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>Liraglutide</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/NCT01664676
org study id: U1111-1131-5236
secondary id: 2012-003577-26
nct id: NCT01664676
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against
      diabetic nephropathy. We hypothesise that this is also the case in humans. This study will
      investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2
      diabetic patients. Impact on basic kidney physiological will be determined and kidney injury
      markers will be measured as surrogate parameters of kidney protection.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
time frame: 10-15 hours post-dose
measure: Renal Blood Flow (functional magnetic resonance imaging)
time frame: 15 hours post-dose
measure: Renal electrolyte clearance
time frame: 10-15 hours post-dose
description: Sodium, potassium, calcium, lithium and osmotically active substances.
measure: Excretion of kidney injury markers
time frame: 0-10 hours and 10-15 hours post-dose
description: Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
measure: Plasma concentrations of various hormones
time frame: 10-15 hours post-dose
description: Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.
arm group label: Liraglutide
arm group type: Experimental
description: 1.2 mg liraglutide sc. (single-dose)
arm group label: Placebo-liraglutide
arm group type: Placebo Comparator
description: Placebo liraglutide sc. (single-dose)
intervention type: Drug
intervention name: Liraglutide
arm group label: Liraglutide
other name: Victoza
intervention type: Drug
intervention name: Placebo-liraglutide
arm group label: Placebo-liraglutide
other name: Isotonic saline
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jens S Christiansen, Professor
role: Principal Investigator
affiliation: Aarhus University Hospital, Department of Endocrinology and Diabetes
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide