Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Insomnia; Sleep Disorder; Inflammation
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Intervention: Suvorexant; Placebo
Intervention description: 10-mg or 20-mg Suvorexant capsules; Matching placebo capsules
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 108.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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