Phase 4
Completed N=67
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Source: ClinicalTrials.gov NCT03818581 ↗Enrolled (actual)
67
Serious AEs
0.8%
Results posted
Mar 2023
Primary outcomePrimary: Subjective Total Sleep Time — 6.4; 7.0; 6.7; 6.7 hours — p=0.15
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Total Sleep Time |
6.4; 7.0; 6.7; 6.7 | 0.15 |
| SECONDARY Subjective Wake After Sleep Onset |
62.4; 31.4; 36.7; 48.3 | — |
| SECONDARY Insomnia Severity Index |
7.1; 5.6; 10.9; 9.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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, 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03818581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.