<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/NCT01680185</url>
  </required_header>
  <id_info>
    <org_study_id>SAPT-NODAT_9march2012</org_study_id>
    <nct_id>NCT01680185</nct_id>
  </id_info>
  <brief_title>Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation</brief_title>
  <acronym>SAPT-NODAT</acronym>
  <official_title>Treat-To-Target Trial of Continuous Subcutaneous, Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment&#xD;
      with short acting insulin, applied continuously through an insulin pump, (i) improves&#xD;
      glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers&#xD;
      further β-cell protection, in comparison to the standard of care control group, and the basal&#xD;
      insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented&#xD;
      insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic&#xD;
      events. Patients in the SAPT-NODAT study will be followed through 24 months&#xD;
      post-transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: New-onset diabetes after transplantation (NODAT) is strongly associated with&#xD;
      postoperative hyperglycemia, and reduced patient as well as graft survival. In our recent&#xD;
      proof-of-concept clinical trial (TIP), we have shown that immediate post-transplant basal&#xD;
      insulin therapy decreases hyperglycemia and reduces the prevalence of NODAT by improving&#xD;
      pancreatic β-cell function. In consequence, a collaborative multicenter study on NODAT&#xD;
      prevention using basal insulin has been approved by the National Institutes of Health (NIH),&#xD;
      and will start recruiting 380 patients at 6 international transplant centers, including the&#xD;
      Medical University of Vienna and the University of Michigan in 2012. In addition to the&#xD;
      NIH-sponsored trial, the Vienna SAPT-NODAT study will test the hypotheses that intensive&#xD;
      subcutaneous insulin treatment with short acting insulin, applied continuously through an&#xD;
      insulin pump in combination with a glucose sensor (SAPT), (i) improves glycemic control, (ii)&#xD;
      reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection,&#xD;
      in comparison to the standard of care control group, and the basal insulin treatment group.&#xD;
&#xD;
      Methods: Combining the NIH-sponsored basal insulin study and the SAPT-NODAT study will yield&#xD;
      three study arms, with 28 patients in each arm, namely: [1] the control arm, treated by&#xD;
      standard-of-care; [2] the basal insulin arm, treated predominantly with intermediate acting&#xD;
      NPH insulin (human insulin isophane, Humulin N, Eli Lilly); [3] the SAPT arm, treated with&#xD;
      short acting insulin (Insulin lispro, Humalog, Eli Lilly), applied continuously by SAPT&#xD;
      technology. Adult patients with absence of diabetes will be randomized prior to renal&#xD;
      transplantation and stratified by deceased donor or living donor, if they are capable of&#xD;
      understanding the study and are willing to give informed written consent for all three study&#xD;
      arms. Patients will receive standard triple immunosuppressive medications (twice-daily&#xD;
      tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids) with predefined&#xD;
      tacrolimus targets and steroid doses. The algorithm for insulin administration is designed to&#xD;
      account for the prominent evening peak of hyperglycemia observed in our previous TIP-study.&#xD;
      The primary endpoint is HbA1c (in rel.%), at 3 months, and superiority will be assumed if a&#xD;
      statistically significant difference between the SAPT-treatment group versus the&#xD;
      standard-of-care control group can be determined, by two-sided Student's t-test. Secondary&#xD;
      endpoints will be compared between all three groups and will include hypoglycemic events,&#xD;
      glycemic variability, 2h glucose ≥200 mg/dL (by oral glucose tolerance test [OGTT] to&#xD;
      determine prevalence of diabetes, prediabetes and normal glucose tolerance), beta cell&#xD;
      function and insulin sensitivity derived from OGTT, serum creatinine, quality of life&#xD;
      measures, patient and graft survival. All secondary endpoint comparisons relying on OGTTs&#xD;
      will be made at 6, 12 and 24 months after kidney transplantation, respectively. The result of&#xD;
      the 6-months OGTT will be blinded to patients and investigators to prevent subsequent&#xD;
      treatment bias.&#xD;
&#xD;
      Discussion: Basal insulin treatment in our previous proof-of-concept study could not prevent&#xD;
      a high number of transplant patients exhibiting overt prediabetes (impaired glucose&#xD;
      tolerance) at 3, 6 and 12 months, probably on the basis that hyperglycemia was improved, but&#xD;
      far from being aggressively treated in patients receiving basal insulin. Prediabetes however&#xD;
      is an independent predictor of all-cause mortality in patients after renal transplantation,&#xD;
      and therefore not only a harbinger of overt diabetes mellitus but rather a high-risk&#xD;
      condition per se. The use of HbA1c as primary endpoint at three months is debatable, but&#xD;
      necessary to determine whether SAPT technology may lead to a clinically meaningful&#xD;
      improvement of overall glucose control. Specifically, in our previous study (TIP), we&#xD;
      observed an intra-individual rise in HbA1c (0.5±0.7 rel.%) from baseline to 3 months, despite&#xD;
      basal insulin treatment. If the intra-individual rise in the SAPT arm will remain below that&#xD;
      value, SAPT technology could be considered to be a clinically meaningful improvement. The&#xD;
      SAPT-NODAT study, besides holding promise to further improve glycemic control, thereby&#xD;
      reducing diabetes, prediabetes and possibly cardiovascular events after transplantation, may&#xD;
      ensure that the present team of investigators continues to take the lead in post-transplant&#xD;
      insulin administration, which is emerging as a central focus in NODAT-prevention and may soon&#xD;
      reach broader clinical application.&#xD;
&#xD;
      (Study approval: EK-Nr. 10/2012)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>3 months after transplantation</time_frame>
    <description>HbA1c levels, in relative %, at 3 months. Superiority will be assumed if a statistically significant difference between the SAPT-treatment group versus the control group (from the ITP-NODAT study) can be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>3, 6, 12, 24 months after transplantation</time_frame>
    <description>HbA1c, in relative %, at 3, 6, 12 and 24 months post-transplantation; The baseline measurement will also be subtracted from the 3-, 6-, 12-, and 24-months measurement (i.e. &quot;3-months, 6-months, 12-months, and 24-months HbA1c minus baseline HbA1c&quot;). For the determination of the intra-individual rise in HbA1c, the previously observed rise of 0.5±0.7 % (mean ± standard deviation) from baseline to 3 months in the TIP-study basal insulin treatment group will be judged to be clinically not meaningful, hence if the intra-individual rise in the SAPT-treatment group remains below that value, the rise in HbA1c will be considered to be not meaningful, clinically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral glucose tolerance test (OGTT)-derived 2 hour-glucose</measure>
    <time_frame>6, 12, 24 months after transplantation</time_frame>
    <description>2h glucose ≥200 mg/dL, as by OGTT at 6, 12 and 24 months after transplantation (in comparison to the simultaneously monitored control group of the ITP-NODAT study [=arm B; control])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>6, 12, 24 months after transplantation</time_frame>
    <description>Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta cell function</measure>
    <time_frame>6, 12, 24 months after transplantation</time_frame>
    <description>Insulinogenic index during an OGTT at 6, 12 and 24 months after kidney transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>6, 12, 24 months after transplantation</time_frame>
    <description>Oral glucose insulin sensitivity (OGIS) index at 6, 12 and 24 months after kidney transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily glucose measurements</measure>
    <time_frame>Daily glucose measurements will be obtained during the hopital stay and while patients are injecting insulin, during an expected average of 3 months.</time_frame>
    <description>Daily glycemia profile, through evaluation of all available glucose measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>6, 12 and 24 months after transplantation</time_frame>
    <description>Serum creatinine at 6, 12 and 24 months after kidney transplantation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Sensor-augmented Insulin Pump</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NPH insulin titration regimen, as specified in the IPT-NODAT study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned in this arm will receive standard of care following their kidney transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin lispro, Humalog (Eli Lilly) in insulin pump</intervention_name>
    <description>all covered above</description>
    <arm_group_label>Sensor-augmented Insulin Pump</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human insulin isophane, Humulin N (Eli Lilly)</intervention_name>
    <description>all covered above</description>
    <arm_group_label>Basal insulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>all covered above</description>
    <arm_group_label>Standard of care</arm_group_label>
    <other_name>Sliding scale short acting insulin for hyperglycemi; Sulphonylurea for NODAT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with end stage renal disease undergoing kidney transplantation with a&#xD;
             deceased or living donor kidney.&#xD;
&#xD;
          -  Absence of diabetes prior to kidney transplantation, defined according to American&#xD;
             Diabetes Association guideline (not on oral hypoglycemic agents or insulin with&#xD;
             fasting glucose &lt;126 mg/dL).&#xD;
&#xD;
          -  Receiving standard triple immunosuppressive medications that include tacrolimus,&#xD;
             mycophenolate mofetil or mycophenolic sodium and steroids.&#xD;
&#xD;
          -  Capable of understanding the study and willing to give informed written consent for&#xD;
             study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or&#xD;
             receiving anti-diabetic medications, or having pre-transplant fasting glucose level&#xD;
             equal or greater than 126 mg/dL on two occasions at least three days apart.&#xD;
&#xD;
          -  Patients receiving an organ transplant other than kidney.&#xD;
&#xD;
          -  Patients receiving an unlicensed drug or therapy within one month prior to study&#xD;
             entry.&#xD;
&#xD;
          -  Patients with history of hypersensitivity to injectable insulin.&#xD;
&#xD;
          -  Patients with documented HIV infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus D Säemann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>June 5, 2018</last_update_submitted>
  <last_update_submitted_qc>June 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Marcus Saemann</investigator_full_name>
    <investigator_title>Prof. Dr. Marcus Säemann</investigator_title>
  </responsible_party>
  <keyword>Hyperglycemia</keyword>
  <keyword>NODAT</keyword>
  <keyword>Insulin pump</keyword>
  <keyword>Semiclosed loop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
    <mesh_term>Isophane Insulin, Human</mesh_term>
    <mesh_term>Insulin, Isophane</mesh_term>
    <mesh_term>Isophane insulin, beef</mesh_term>
    <mesh_term>Insulin, Short-Acting</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/NCT01680185
org study id: SAPT-NODAT_9march2012
nct id: NCT01680185
lead sponsor: 
has dmc: No
The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment
      with short acting insulin, applied continuously through an insulin pump, (i) improves
      glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers
      further β-cell protection, in comparison to the standard of care control group, and the basal
      insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented
      insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic
      events. Patients in the SAPT-NODAT study will be followed through 24 months
      post-transplantation.
Introduction: New-onset diabetes after transplantation (NODAT) is strongly associated with
      postoperative hyperglycemia, and reduced patient as well as graft survival. In our recent
      proof-of-concept clinical trial (TIP), we have shown that immediate post-transplant basal
      insulin therapy decreases hyperglycemia and reduces the prevalence of NODAT by improving
      pancreatic β-cell function. In consequence, a collaborative multicenter study on NODAT
      prevention using basal insulin has been approved by the National Institutes of Health (NIH),
      and will start recruiting 380 patients at 6 international transplant centers, including the
      Medical University of Vienna and the University of Michigan in 2012. In addition to the
      NIH-sponsored trial, the Vienna SAPT-NODAT study will test the hypotheses that intensive
      subcutaneous insulin treatment with short acting insulin, applied continuously through an
      insulin pump in combination with a glucose sensor (SAPT), (i) improves glycemic control, (ii)
      reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection,
      in comparison to the standard of care control group, and the basal insulin treatment group.

      Methods: Combining the NIH-sponsored basal insulin study and the SAPT-NODAT study will yield
      three study arms, with 28 patients in each arm, namely: [1] the control arm, treated by
      standard-of-care; [2] the basal insulin arm, treated predominantly with intermediate acting
      NPH insulin (human insulin isophane, Humulin N, Eli Lilly); [3] the SAPT arm, treated with
      short acting insulin (Insulin lispro, Humalog, Eli Lilly), applied continuously by SAPT
      technology. Adult patients with absence of diabetes will be randomized prior to renal
      transplantation and stratified by deceased donor or living donor, if they are capable of
      understanding the study and are willing to give informed written consent for all three study
      arms. Patients will receive standard triple immunosuppressive medications (twice-daily
      tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids) with predefined
      tacrolimus targets and steroid doses. The algorithm for insulin administration is designed to
      account for the prominent evening peak of hyperglycemia observed in our previous TIP-study.
      The primary endpoint is HbA1c (in rel.%), at 3 months, and superiority will be assumed if a
      statistically significant difference between the SAPT-treatment group versus the
      standard-of-care control group can be determined, by two-sided Student's t-test. Secondary
      endpoints will be compared between all three groups and will include hypoglycemic events,
      glycemic variability, 2h glucose ≥200 mg/dL (by oral glucose tolerance test [OGTT] to
      determine prevalence of diabetes, prediabetes and normal glucose tolerance), beta cell
      function and insulin sensitivity derived from OGTT, serum creatinine, quality of life
      measures, patient and graft survival. All secondary endpoint comparisons relying on OGTTs
      will be made at 6, 12 and 24 months after kidney transplantation, respectively. The result of
      the 6-months OGTT will be blinded to patients and investigators to prevent subsequent
      treatment bias.

      Discussion: Basal insulin treatment in our previous proof-of-concept study could not prevent
      a high number of transplant patients exhibiting overt prediabetes (impaired glucose
      tolerance) at 3, 6 and 12 months, probably on the basis that hyperglycemia was improved, but
      far from being aggressively treated in patients receiving basal insulin. Prediabetes however
      is an independent predictor of all-cause mortality in patients after renal transplantation,
      and therefore not only a harbinger of overt diabetes mellitus but rather a high-risk
      condition per se. The use of HbA1c as primary endpoint at three months is debatable, but
      necessary to determine whether SAPT technology may lead to a clinically meaningful
      improvement of overall glucose control. Specifically, in our previous study (TIP), we
      observed an intra-individual rise in HbA1c (0.5±0.7 rel.%) from baseline to 3 months, despite
      basal insulin treatment. If the intra-individual rise in the SAPT arm will remain below that
      value, SAPT technology could be considered to be a clinically meaningful improvement. The
      SAPT-NODAT study, besides holding promise to further improve glycemic control, thereby
      reducing diabetes, prediabetes and possibly cardiovascular events after transplantation, may
      ensure that the present team of investigators continues to take the lead in post-transplant
      insulin administration, which is emerging as a central focus in NODAT-prevention and may soon
      reach broader clinical application.

      (Study approval: EK-Nr. 10/2012)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Glycosylated hemoglobin (HbA1c)
time frame: 3 months after transplantation
description: HbA1c levels, in relative %, at 3 months. Superiority will be assumed if a statistically significant difference between the SAPT-treatment group versus the control group (from the ITP-NODAT study) can be determined.
measure: Glycosylated hemoglobin (HbA1c)
time frame: 3, 6, 12, 24 months after transplantation
description: HbA1c, in relative %, at 3, 6, 12 and 24 months post-transplantation; The baseline measurement will also be subtracted from the 3-, 6-, 12-, and 24-months measurement (i.e. "3-months, 6-months, 12-months, and 24-months HbA1c minus baseline HbA1c"). For the determination of the intra-individual rise in HbA1c, the previously observed rise of 0.5±0.7 % (mean ± standard deviation) from baseline to 3 months in the TIP-study basal insulin treatment group will be judged to be clinically not meaningful, hence if the intra-individual rise in the SAPT-treatment group remains below that value, the rise in HbA1c will be considered to be not meaningful, clinically.
measure: Oral glucose tolerance test (OGTT)-derived 2 hour-glucose
time frame: 6, 12, 24 months after transplantation
description: 2h glucose ≥200 mg/dL, as by OGTT at 6, 12 and 24 months after transplantation (in comparison to the simultaneously monitored control group of the ITP-NODAT study [=arm B; control])
measure: Fasting glucose
time frame: 6, 12, 24 months after transplantation
description: Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation.
measure: Beta cell function
time frame: 6, 12, 24 months after transplantation
description: Insulinogenic index during an OGTT at 6, 12 and 24 months after kidney transplantation
measure: Insulin sensitivity
time frame: 6, 12, 24 months after transplantation
description: Oral glucose insulin sensitivity (OGIS) index at 6, 12 and 24 months after kidney transplantation
measure: Daily glucose measurements
time frame: Daily glucose measurements will be obtained during the hopital stay and while patients are injecting insulin, during an expected average of 3 months.
description: Daily glycemia profile, through evaluation of all available glucose measurements
measure: Serum creatinine
time frame: 6, 12 and 24 months after transplantation
description: Serum creatinine at 6, 12 and 24 months after kidney transplantation
arm group label: Sensor-augmented Insulin Pump
arm group type: Active Comparator
description: Continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation.
arm group label: Basal insulin
arm group type: Active Comparator
description: NPH insulin titration regimen, as specified in the IPT-NODAT study
arm group label: Standard of care
arm group type: Active Comparator
description: Patients assigned in this arm will receive standard of care following their kidney transplantation
intervention type: Drug
intervention name: Insulin lispro, Humalog (Eli Lilly) in insulin pump
description: all covered above
arm group label: Sensor-augmented Insulin Pump
intervention type: Drug
intervention name: Human insulin isophane, Humulin N (Eli Lilly)
description: all covered above
arm group label: Basal insulin
intervention type: Other
intervention name: Standard of care
description: all covered above
arm group label: Standard of care
other name: Sliding scale short acting insulin for hyperglycemi; Sulphonylurea for NODAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus D Säemann, MD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Marcus Saemann
investigator title: Prof. Dr. Marcus Säemann
mesh term: Hyperglycemia
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Lispro
mesh term: Isophane Insulin, Human
mesh term: Insulin, Isophane
mesh term: Isophane insulin, beef
mesh term: Insulin, Short-Acting