At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 108 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Suvorexant and Placebo for Type 2 Diabetes Mellitus and 3 related conditions. Completed, enrolled 108 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Insomnia, Sleep Disorder, Inflammation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMar 2019
Primary CompletionNov 2021
TodayJul 2026
First PostedJan 28, 2019
Enrollment StartMar 15, 2019
Primary CompletionNov 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.4 years ago
Interventions
Suvorexantdrug
10-mg or 20-mg Suvorexant capsules
Placeboother
Matching placebo capsules