Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

NCT03818581 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019P000076
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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 trial for 3 months.

Conditions

Type 2 Diabetes Mellitus; Insomnia; Sleep Disorder; Inflammation

Outcome Measures

Primary Outcomes (1)

• Subjective Total Sleep Time

  Total sleep time as reported on daily sleep diaries

  2 weeks

Secondary Outcomes (2)

• Subjective Wake After Sleep Onset

  2 weeks

• Insomnia Severity Index

  2 weeks

Study Arms (4)

Treatment Group

ACTIVE COMPARATOR

Drug: Suvorexant

Placebo Responders

PLACEBO COMPARATOR

Other: Placebo

Placebo Non-responders Re-randomized to Treatment

ACTIVE COMPARATOR

Drug: Suvorexant; Other: Placebo

Placebo Non-responders Re-randomized to Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Suvorexant DRUG

10-mg or 20-mg Suvorexant capsules

Also known as: Belsomra

Placebo Non-responders Re-randomized to Treatment; Treatment Group

Placebo OTHER

Matching placebo capsules

Placebo Non-responders Re-randomized to Placebo; Placebo Non-responders Re-randomized to Treatment; Placebo Responders

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Inflammation

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Dr. John Winkelman
• Organization: Massachusetts General Hospital

jwwinkelman@mgh.harvard.edu

617-643-9101

Study Officials

• John W Winkelman, MD/PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Sleep Disorders Clinical Research Program

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: March 15, 2019
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: August 20, 2024
• Results First Posted: March 2, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)