<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/NCT03818581</url>
  </required_header>
  <id_info>
    <org_study_id>2019P000076</org_study_id>
    <nct_id>NCT03818581</nct_id>
  </id_info>
  <brief_title>Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes</brief_title>
  <official_title>Effect of Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes: A Randomized 3-month Clinical Trial Using a Sequential Parallel Comparison Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to determine the effect of suvorexant on subjective total sleep time&#xD;
      (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized&#xD;
      placebo-controlled trial for 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 diabetes results from a progressive insulin secretory defect on the background of&#xD;
      insulin resistance and is a growing pandemic and a leading cause of morbidity and mortality.&#xD;
      Sleep disturbance is one of the underappreciated and important features of Type 2 diabetes,&#xD;
      and may contribute to the development of the disease. In those with established Type 2&#xD;
      diabetes, there is emerging evidence from cross-sectional studies that sleep disturbance&#xD;
      affects glycemic control. Although cross-sectional studies suggest a relationship between&#xD;
      sleep disturbance and glycemic control in Type 2 diabetes, causality is best investigated by&#xD;
      interventional studies. Suvorexant has a comparatively benign side effect profile compared to&#xD;
      many of the hypnotic agents typically prescribed for insomnia. The investigators aim to&#xD;
      determine the effect of suvorexant on subjective total sleep time (TST), as well as&#xD;
      subjective wake after sleep onset, Insomnia Severity Index, HbA1c levels and insulin&#xD;
      sensitivity, inflammatory markers, and other subjective sleep endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</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>
    <intervention_model_description>Sequential Parallel Comparison Design: subjects will be randomized in a 1:2 ratio to suvorexant 10-20 mg or equivalent placebo for six weeks, followed by re-randomization of placebo non-responders to either suvorexant or placebo in a 1:1 design for six weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The participant, investigator, and clinical research coordinator will remain masked throughout the duration of the study. An unmasked research coordinator will be responsible for assessing mid-point outcomes on the sleep diaries and communicating with the pharmacy for re-randomization medication orders.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Total Sleep Time</measure>
    <time_frame>2 weeks</time_frame>
    <description>Total sleep time as reported on daily sleep diaries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Wake After Sleep Onset</measure>
    <time_frame>2 weeks</time_frame>
    <description>Total time awake after sleep onset as reported on daily sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>2 weeks</time_frame>
    <description>A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Insomnia</condition>
  <condition>Sleep Disorder</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Responders</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Non-responders Re-randomized to Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Non-responders Re-randomized to Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Suvorexant</intervention_name>
    <description>10-mg or 20-mg Suvorexant capsules</description>
    <arm_group_label>Placebo Non-responders Re-randomized to Treatment</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>Belsomra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo capsules</description>
    <arm_group_label>Placebo Non-responders Re-randomized to Placebo</arm_group_label>
    <arm_group_label>Placebo Non-responders Re-randomized to Treatment</arm_group_label>
    <arm_group_label>Placebo Responders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women of any ethnic origin&#xD;
&#xD;
          2. Written informed consent is obtained&#xD;
&#xD;
          3. Speaks and writes in English&#xD;
&#xD;
          4. A willingness and ability to comply with study procedures.&#xD;
&#xD;
          5. Age 25-75 years&#xD;
&#xD;
          6. Diagnosis of Type 2 diabetes with suboptimally controlled blood sugar determined by&#xD;
             HbA1c &gt; 6.5% (and &lt; 10.0%) at both the screening and randomization visits&#xD;
&#xD;
          7. No changes in diabetes medication in the previous month&#xD;
&#xD;
          8. DSM-5 criteria for Insomnia Disorder&#xD;
&#xD;
          9. Score on the Insomnia Severity Index (ISI) measure &gt;10, indicating at least a moderate&#xD;
             level of insomnia symptoms2&#xD;
&#xD;
         10. Report a total sleep time ≤ 6.5 hours and combined sleep onset latency (SOL) and wake&#xD;
             after sleep onset (WASO) &gt; 45 minutes on 7 or more of the 14 nightly sleep logs during&#xD;
             both the initial 2-week screening period and the two-week screening run-in period.&#xD;
             Combined SOL and WASO does not decrease by more than 50% on the 2-week sleep diary&#xD;
             obtained between the screening visit and the randomization visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sleep and medical factors:&#xD;
&#xD;
               1. Diagnosis of severe obstructive sleep apnea not using CPAP (can be included if&#xD;
                  CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy,&#xD;
                  moderate to severe restless legs syndrome)&#xD;
&#xD;
               2. Shift workers&#xD;
&#xD;
               3. Use of hypnotic medications more than twice per week in the past month&#xD;
&#xD;
               4. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the&#xD;
                  study period&#xD;
&#xD;
               5. Unwillingness to maintain stable diabetes medication during the study unless&#xD;
                  medically indicated&#xD;
&#xD;
               6. Positive urine toxic screen for any drugs of abuse other than marijuana at&#xD;
                  Screening Visit&#xD;
&#xD;
               7. HbA1c ≥ 10.0% at either the screening or randomization visit&#xD;
&#xD;
          2. Psychiatric factors:&#xD;
&#xD;
               1. Current major depressive episode, by report and as indicated by the Quick&#xD;
                  Inventory of Depressive Symptoms-Self Report (QIDS-SR).&#xD;
&#xD;
               2. Subjects with active or unstable major psychiatric disorder, who, in the&#xD;
                  investigator's judgement, require further treatment.&#xD;
&#xD;
               3. Current alcohol/substance use disorder&#xD;
&#xD;
          3. Medical factors:&#xD;
&#xD;
               1. Renal or hepatic disease judged to interfere with drug metabolism and excretion&#xD;
&#xD;
               2. Pregnant or breastfeeding&#xD;
&#xD;
               3. Malignancy within past 2 years&#xD;
&#xD;
               4. Surgery within past 3 months&#xD;
&#xD;
               5. Neurological disorder or cardiovascular disease raising safety concerns about use&#xD;
                  of suvorexant and/or judged to interfere with ability to assess efficacy of the&#xD;
                  treatment&#xD;
&#xD;
               6. Medical instability considered to interfere with study procedures&#xD;
&#xD;
               7. Concomitant medications with drug interaction or co-administration concerns&#xD;
&#xD;
               8. Contraindications or allergic responses to suvorexant&#xD;
&#xD;
               9. History of being treated with suvorexant&#xD;
&#xD;
          4. Lifestyle and other factors:&#xD;
&#xD;
               1. Travel across two time-zones during the week prior to enrollment&#xD;
&#xD;
               2. Greater than 6 cups of coffee per day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John W Winkelman, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>November 5, 2022</results_first_submitted>
  <results_first_submitted_qc>February 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2023</results_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>John Winkelman, MD, PhD</investigator_full_name>
    <investigator_title>Chief, Sleep Disorders Clinical Research Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suvorexant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03818581/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>108 participants were enrolled. 36 participants did not meet the eligibility criteria post-enrollment, but pre-randomization. 3 additional participants were removed prior to randomization from the study due to protocol non-adherence. A total of 39 participants who were enrolled were not randomized to the study, leaving a total of 69 participants who were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>Suvorexant capsules: 10-mg or 20-mg</description>
        </group>
        <group group_id="P2">
          <title>Placebo Responders</title>
          <description>Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="P3">
          <title>Placebo Non-responders Re-randomized to Treatment</title>
          <description>Suvorexant capsules: 10-mg or 20-mg&#xD;
Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="P4">
          <title>Placebo Non-responders Re-randomized to Placebo</title>
          <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="P5">
          <title>Placebo</title>
          <description>Discontinued or withdrew before randomization 2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Covid-19</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer met study criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any baseline or follow-up data could be collected. An additional 3 participants in the treatment group dropped out, leaving 20 participants with interpretable data.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules</description>
        </group>
        <group group_id="B2">
          <title>Placebo Responders</title>
          <description>Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="B3">
          <title>Placebo Non-responders Re-randomized to Treatment</title>
          <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules&#xD;
Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="B4">
          <title>Placebo Non-responders Re-randomized to Placebo</title>
          <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" spread="8.5"/>
                    <measurement group_id="B2" value="60.6" spread="7.1"/>
                    <measurement group_id="B3" value="61.4" spread="8.4"/>
                    <measurement group_id="B4" value="58.3" spread="10.1"/>
                    <measurement group_id="B5" value="60.5" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjective Total Sleep Time</title>
          <description>Subjective Total Sleep Time was measured by asking participants the question: &quot;What was the total amount of sleep that you got last night?&quot;&#xD;
This question was asked every day for 2 weeks at baseline. Each participants baseline score was an average of their responses to that question.</description>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.5" spread="0.7"/>
                    <measurement group_id="B2" value="5.6" spread="0.9"/>
                    <measurement group_id="B3" value="6.3" spread="0.7"/>
                    <measurement group_id="B4" value="6.1" spread="0.7"/>
                    <measurement group_id="B5" value="5.9" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insomnia Severity Index</title>
          <description>The Insomnia Severity Index measures insomnia severity on a scale from 0-28, with higher scores indicating worse insomnia severity than lower scores.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="3.2"/>
                    <measurement group_id="B2" value="17.3" spread="3.6"/>
                    <measurement group_id="B3" value="17.3" spread="3.1"/>
                    <measurement group_id="B4" value="16.8" spread="3.8"/>
                    <measurement group_id="B5" value="16.1" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wake After Sleep Onset</title>
          <description>Wake After Sleep Onset was measured by asking participants the question: &quot;How long were you awake, in total, between the time you fell asleep and before your final awakening?&quot;&#xD;
This question was asked every day for 2 weeks at baseline. Each participants baseline score was an average of their responses to that question.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.2" spread="50.7"/>
                    <measurement group_id="B2" value="73.8" spread="41.9"/>
                    <measurement group_id="B3" value="64.8" spread="42.3"/>
                    <measurement group_id="B4" value="73.1" spread="46.7"/>
                    <measurement group_id="B5" value="76.1" spread="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Calculated Total Sleep Time</title>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0" spread="0.8"/>
                    <measurement group_id="B2" value="5.6" spread="0.9"/>
                    <measurement group_id="B3" value="6.4" spread="0.7"/>
                    <measurement group_id="B4" value="6.2" spread="0.7"/>
                    <measurement group_id="B5" value="5.9" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Awakenings</title>
          <units>Number of Awakenings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.4" spread="1.0"/>
                    <measurement group_id="B2" value="1.5" spread="0.8"/>
                    <measurement group_id="B3" value="2.1" spread="1.1"/>
                    <measurement group_id="B4" value="2.2" spread="1.2"/>
                    <measurement group_id="B5" value="2.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pittsburgh Sleep Quality Index</title>
          <description>The Pittsburgh Sleep Quality Index measures sleep quality on a scale from 0-21, with higher scores indicating worse sleep quality than lower scores.&#xD;
For the purposes of this study, we only used scores from question 6: &quot;During the past month, how would you rate your sleep quality overall?&quot;&#xD;
This question is scored from 0-3, with 0 being better sleep quality and 3 being worse sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.8" spread="0.4"/>
                    <measurement group_id="B2" value="2.3" spread="0.8"/>
                    <measurement group_id="B3" value="2.1" spread="0.5"/>
                    <measurement group_id="B4" value="2" spread="0.7"/>
                    <measurement group_id="B5" value="2.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sleep Onset Latency</title>
          <description>Sleep Onset Latency was measured by asking participants the question: &quot;How long did it take you to fall asleep?&quot;&#xD;
This question was asked every day for 2 weeks at baseline. Each participants baseline score was an average of their responses to that question.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.1" spread="17.2"/>
                    <measurement group_id="B2" value="47.1" spread="33.7"/>
                    <measurement group_id="B3" value="34.9" spread="26.5"/>
                    <measurement group_id="B4" value="29.0" spread="19.0"/>
                    <measurement group_id="B5" value="34.9" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sleep Efficiency</title>
          <description>Sleep Efficiency is calculated by the following equation: (Total sleep time)/(Time in bed) * 100%&#xD;
This information was collected over a 2-week period and then averaged to find each participants baseline score.</description>
          <units>% of time sleeping/time in bed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.7" spread="0.1"/>
                    <measurement group_id="B2" value="80.4" spread="0.03"/>
                    <measurement group_id="B3" value="82.9" spread="0.09"/>
                    <measurement group_id="B4" value="80.0" spread="0.09"/>
                    <measurement group_id="B5" value="79.2" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beck's Depression Inventory</title>
          <description>The Beck's Depression Inventory measures depressive symptoms on a scale from 0-63, with higher scores indicating more severe depression than lower scores.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="5.1"/>
                    <measurement group_id="B2" value="9.4" spread="4.6"/>
                    <measurement group_id="B3" value="12.1" spread="8.3"/>
                    <measurement group_id="B4" value="9.3" spread="6.8"/>
                    <measurement group_id="B5" value="9.7" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Quality of Life</title>
          <description>The Diabetes Quality of Life scale measures the quality of life among diabetes patients on a scale from 0-60, with higher scores indicating lower quality of life than lower scores.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="5.1"/>
                    <measurement group_id="B2" value="9.4" spread="4.6"/>
                    <measurement group_id="B3" value="12.1" spread="8.3"/>
                    <measurement group_id="B4" value="9.3" spread="6.8"/>
                    <measurement group_id="B5" value="9.7" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Distress Scale</title>
          <description>The Diabetes Distress scale measures the distress felt by diabetes patients on a scale from 17-102, with higher scores indicating more distress than lower scores.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.9" spread="13.2"/>
                    <measurement group_id="B2" value="34.1" spread="18.9"/>
                    <measurement group_id="B3" value="33" spread="12.7"/>
                    <measurement group_id="B4" value="33.3" spread="12.4"/>
                    <measurement group_id="B5" value="33.3" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>% of total hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.7" spread="1.0"/>
                    <measurement group_id="B2" value="7.5" spread="0.9"/>
                    <measurement group_id="B3" value="7.5" spread="0.9"/>
                    <measurement group_id="B4" value="7.7" spread="0.7"/>
                    <measurement group_id="B5" value="7.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CRP</title>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="8.9"/>
                    <measurement group_id="B2" value="8.2" spread="7.5"/>
                    <measurement group_id="B3" value="5.7" spread="8.3"/>
                    <measurement group_id="B4" value="6.0" spread="10.2"/>
                    <measurement group_id="B5" value="6.4" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Total Sleep Time</title>
        <description>Total sleep time as reported on daily sleep diaries</description>
        <time_frame>2 weeks</time_frame>
        <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 1 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Suvorexant capsules: 10-mg or 20-mg</description>
          </group>
          <group group_id="O2">
            <title>Placebo Responders</title>
            <description>Placebo: Matching placebo capsules</description>
          </group>
          <group group_id="O3">
            <title>Placebo Non-responders Re-randomized to Treatment</title>
            <description>Placebo: Matching placebo capsules&#xD;
Suvorexant capsules: 10-mg or 20-mg</description>
          </group>
          <group group_id="O4">
            <title>Placebo Non-responders Re-randomized to Placebo</title>
            <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Total Sleep Time</title>
          <description>Total sleep time as reported on daily sleep diaries</description>
          <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 1 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.8"/>
                    <measurement group_id="O2" value="7.0" spread="0.9"/>
                    <measurement group_id="O3" value="6.7" spread="0.8"/>
                    <measurement group_id="O4" value="6.7" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>SPCD analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Wake After Sleep Onset</title>
        <description>Total time awake after sleep onset as reported on daily sleep diaries</description>
        <time_frame>2 weeks</time_frame>
        <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 2 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules</description>
          </group>
          <group group_id="O2">
            <title>Placebo Responders</title>
            <description>Placebo: Matching placebo capsules</description>
          </group>
          <group group_id="O3">
            <title>Placebo Non-responders Re-randomized to Treatment</title>
            <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules&#xD;
Placebo: Matching placebo capsules</description>
          </group>
          <group group_id="O4">
            <title>Placebo Non-responders Re-randomized to Placebo</title>
            <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Wake After Sleep Onset</title>
          <description>Total time awake after sleep onset as reported on daily sleep diaries</description>
          <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 2 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.4" spread="49.6"/>
                    <measurement group_id="O2" value="31.4" spread="21.0"/>
                    <measurement group_id="O3" value="36.7" spread="25.8"/>
                    <measurement group_id="O4" value="48.3" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insomnia Severity Index</title>
        <description>A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.</description>
        <time_frame>2 weeks</time_frame>
        <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 1 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules</description>
          </group>
          <group group_id="O2">
            <title>Placebo Responders</title>
            <description>Placebo: Matching placebo capsules</description>
          </group>
          <group group_id="O3">
            <title>Placebo Non-responders Re-randomized to Treatment</title>
            <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules&#xD;
Placebo: Matching placebo capsules</description>
          </group>
          <group group_id="O4">
            <title>Placebo Non-responders Re-randomized to Placebo</title>
            <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
          </group>
        </group_list>
        <measure>
          <title>Insomnia Severity Index</title>
          <description>A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.</description>
          <population>The 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section dropped out before any data could be collected. Data from 1 participant in the treatment group, 1 in the placebo non-responders re-randomized to treatment group, and 1 in the placebo non-responders re-randomized to placebo group had to be censored due to quality control issues.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="5.0"/>
                    <measurement group_id="O2" value="5.6" spread="4.1"/>
                    <measurement group_id="O3" value="10.9" spread="5.7"/>
                    <measurement group_id="O4" value="9.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>No adverse event data was collected for the 3 participants in the &quot;placebo&quot; group shown in the &quot;participant flow&quot; section.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules</description>
        </group>
        <group group_id="E2">
          <title>Placebo Responders</title>
          <description>Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="E3">
          <title>Placebo Non-responders Re-randomized to Treatment</title>
          <description>Suvorexant: 10-mg or 20-mg Suvorexant capsules&#xD;
Placebo: Matching placebo capsules</description>
        </group>
        <group group_id="E4">
          <title>Placebo Non-responders Re-randomized to Placebo</title>
          <description>Placebo: Matching placebo capsules&#xD;
Placebo: Matching placebo capsules</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Neuropathy</sub_title>
                <description>Serious case of neuropathy requiring surgical amputation.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Grogginess</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vivid dreams</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. John Winkelman</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-643-9101</phone>
      <email>jwwinkelman@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03818581
org study id: 2019P000076
nct id: NCT03818581
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators aim to determine the effect of suvorexant on subjective total sleep time
      (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized
      placebo-controlled trial for 3 months.
Type 2 diabetes results from a progressive insulin secretory defect on the background of
      insulin resistance and is a growing pandemic and a leading cause of morbidity and mortality.
      Sleep disturbance is one of the underappreciated and important features of Type 2 diabetes,
      and may contribute to the development of the disease. In those with established Type 2
      diabetes, there is emerging evidence from cross-sectional studies that sleep disturbance
      affects glycemic control. Although cross-sectional studies suggest a relationship between
      sleep disturbance and glycemic control in Type 2 diabetes, causality is best investigated by
      interventional studies. Suvorexant has a comparatively benign side effect profile compared to
      many of the hypnotic agents typically prescribed for insomnia. The investigators aim to
      determine the effect of suvorexant on subjective total sleep time (TST), as well as
      subjective wake after sleep onset, Insomnia Severity Index, HbA1c levels and insulin
      sensitivity, inflammatory markers, and other subjective sleep endpoints.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Sequential Parallel Comparison Design: subjects will be randomized in a 1:2 ratio to suvorexant 10-20 mg or equivalent placebo for six weeks, followed by re-randomization of placebo non-responders to either suvorexant or placebo in a 1:1 design for six weeks.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The participant, investigator, and clinical research coordinator will remain masked throughout the duration of the study. An unmasked research coordinator will be responsible for assessing mid-point outcomes on the sleep diaries and communicating with the pharmacy for re-randomization medication orders.
measure: Subjective Total Sleep Time
time frame: 2 weeks
description: Total sleep time as reported on daily sleep diaries
measure: Subjective Wake After Sleep Onset
time frame: 2 weeks
description: Total time awake after sleep onset as reported on daily sleep diaries
measure: Insomnia Severity Index
time frame: 2 weeks
description: A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.
arm group label: Treatment Group
arm group type: Active Comparator
arm group label: Placebo Responders
arm group type: Placebo Comparator
arm group label: Placebo Non-responders Re-randomized to Treatment
arm group type: Active Comparator
arm group label: Placebo Non-responders Re-randomized to Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Suvorexant
description: 10-mg or 20-mg Suvorexant capsules
arm group label: Placebo Non-responders Re-randomized to Treatment
arm group label: Treatment Group
other name: Belsomra
intervention type: Other
intervention name: Placebo
description: Matching placebo capsules
arm group label: Placebo Non-responders Re-randomized to Placebo
arm group label: Placebo Non-responders Re-randomized to Treatment
arm group label: Placebo Responders
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: John W Winkelman, MD/PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: John Winkelman, MD, PhD
investigator title: Chief, Sleep Disorders Clinical Research Program
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Inflammation
mesh term: Suvorexant
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 