Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
NCT03818581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2024-08-20
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.
Conditions
- Type 2 Diabetes Mellitus
- Insomnia
- Sleep Disorder
- Inflammation
Interventions
- DRUG
-
Suvorexant
10-mg or 20-mg Suvorexant capsules
- OTHER
-
Placebo
Matching placebo capsules
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
John W Winkelman, MD/PhD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 25 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-15
- Primary Completion
- 2021-11-03
- Completion
- 2021-11-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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