Status:
COMPLETED
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Type 2 Diabetes Mellitus
Insomnia
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
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 tr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03818581
Start Date
March 15 2019
End Date
November 3 2021
Last Update
August 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114