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Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus, Insomnia, Sleep Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women of any ethnic origin
  2. Written informed consent is obtained
  3. Speaks and writes in English
  4. A willingness and ability to comply with study procedures.
  5. Age 25-75 years
  6. Diagnosis of Type 2 diabetes with suboptimally controlled blood sugar determined by HbA1c > 6.5% (and < 10.0%) at both the screening and randomization visits
  7. No changes in diabetes medication in the previous month
  8. DSM-5 criteria for Insomnia Disorder
  9. Score on the Insomnia Severity Index (ISI) measure >10, indicating at least a moderate level of insomnia symptoms2
  10. Report a total sleep time ≤ 6.5 hours and combined sleep onset latency (SOL) and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. Combined SOL and WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit.

Exclusion Criteria:

  1. Sleep and medical factors:

    1. Diagnosis of severe obstructive sleep apnea not using CPAP (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy, moderate to severe restless legs syndrome)
    2. Shift workers
    3. Use of hypnotic medications more than twice per week in the past month
    4. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
    5. Unwillingness to maintain stable diabetes medication during the study unless medically indicated
    6. Positive urine toxic screen for any drugs of abuse other than marijuana at Screening Visit
    7. HbA1c ≥ 10.0% at either the screening or randomization visit

  2. Psychiatric factors:

    1. Current major depressive episode, by report and as indicated by the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR).
    2. Subjects with active or unstable major psychiatric disorder, who, in the investigator's judgement, require further treatment.
    3. Current alcohol/substance use disorder

  3. Medical factors:

    1. Renal or hepatic disease judged to interfere with drug metabolism and excretion
    2. Pregnant or breastfeeding
    3. Malignancy within past 2 years
    4. Surgery within past 3 months
    5. Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment
    6. Medical instability considered to interfere with study procedures
    7. Concomitant medications with drug interaction or co-administration concerns
    8. Contraindications or allergic responses to suvorexant
    9. History of being treated with suvorexant

  4. Lifestyle and other factors:

    1. Travel across two time-zones during the week prior to enrollment
    2. Greater than 6 cups of coffee per day

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Treatment Group

Placebo Responders

Placebo Non-responders Re-randomized to Treatment

Placebo Non-responders Re-randomized to Placebo

Arm Description

Outcomes

Primary Outcome Measures

Subjective Total Sleep Time
Total sleep time as reported on daily sleep diaries

Secondary Outcome Measures

Subjective Wake After Sleep Onset
Total time awake after sleep onset as reported on daily sleep diaries
Insomnia Severity Index
A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.

Full Information

First Posted
January 24, 2019
Last Updated
February 3, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03818581
Brief Title
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insomnia, Sleep Disorder, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Title
Placebo Responders
Arm Type
Placebo Comparator
Arm Title
Placebo Non-responders Re-randomized to Treatment
Arm Type
Active Comparator
Arm Title
Placebo Non-responders Re-randomized to Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
10-mg or 20-mg Suvorexant capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules
Primary Outcome Measure Information:
Title
Subjective Total Sleep Time
Description
Total sleep time as reported on daily sleep diaries
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Subjective Wake After Sleep Onset
Description
Total time awake after sleep onset as reported on daily sleep diaries
Time Frame
2 weeks
Title
Insomnia Severity Index
Description
A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women of any ethnic origin Written informed consent is obtained Speaks and writes in English A willingness and ability to comply with study procedures. Age 25-75 years Diagnosis of Type 2 diabetes with suboptimally controlled blood sugar determined by HbA1c > 6.5% (and < 10.0%) at both the screening and randomization visits No changes in diabetes medication in the previous month DSM-5 criteria for Insomnia Disorder Score on the Insomnia Severity Index (ISI) measure >10, indicating at least a moderate level of insomnia symptoms2 Report a total sleep time ≤ 6.5 hours and combined sleep onset latency (SOL) and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. Combined SOL and WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit. Exclusion Criteria: Sleep and medical factors: Diagnosis of severe obstructive sleep apnea not using CPAP (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy, moderate to severe restless legs syndrome) Shift workers Use of hypnotic medications more than twice per week in the past month Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period Unwillingness to maintain stable diabetes medication during the study unless medically indicated Positive urine toxic screen for any drugs of abuse other than marijuana at Screening Visit HbA1c ≥ 10.0% at either the screening or randomization visit Psychiatric factors: Current major depressive episode, by report and as indicated by the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR). Subjects with active or unstable major psychiatric disorder, who, in the investigator's judgement, require further treatment. Current alcohol/substance use disorder Medical factors: Renal or hepatic disease judged to interfere with drug metabolism and excretion Pregnant or breastfeeding Malignancy within past 2 years Surgery within past 3 months Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment Medical instability considered to interfere with study procedures Concomitant medications with drug interaction or co-administration concerns Contraindications or allergic responses to suvorexant History of being treated with suvorexant Lifestyle and other factors: Travel across two time-zones during the week prior to enrollment Greater than 6 cups of coffee per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Winkelman, MD/PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

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