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

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ClinicalTrials.gov Identifier: NCT03818581
Recruitment Status : Active, not recruiting
First Posted : January 28, 2019
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
Subjective Total Sleep Time [ Time Frame: 2 weeks ]
Total sleep time as reported on daily sleep diaries
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Subjective Wake After Sleep Onset [ Time Frame: 2 weeks ]
    Total time awake after sleep onset as reported on daily sleep diaries
  • Insomnia Severity Index [ Time Frame: 2 weeks ]
    A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Subjective Wake After Sleep Onset [ Time Frame: 2 weeks ]
    Total time awake after sleep onset as reported on daily sleep diaries
  • Insomnia Severity Index [ Time Frame: 2 weeks ]
    A validated tool to measure insomnia severity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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.
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Insomnia
  • Sleep Disorder
  • Inflammation
Intervention  ICMJE
  • Drug: Suvorexant
    10-mg or 20-mg Suvorexant capsules
    Other Name: Belsomra
  • Other: Placebo
    Matching placebo capsules
Study Arms  ICMJE
  • Active Comparator: Treatment Group
    Intervention: Drug: Suvorexant
  • Placebo Comparator: Placebo Responders
    Intervention: Other: Placebo
  • Active Comparator: Placebo Non-responders Re-randomized to Treatment
    Interventions:
    • Drug: Suvorexant
    • Other: Placebo
  • Placebo Comparator: Placebo Non-responders Re-randomized to Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 31, 2021)
107
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
86
Estimated Study Completion Date  ICMJE September 15, 2021
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03818581
Other Study ID Numbers  ICMJE 2019P000076
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Winkelman, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John W Winkelman, MD/PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP