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

NCT ID: NCT03818581

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2021-11-03

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.

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 is one of the underappreciated and important features of Type 2 diabetes, and may contribute to the development of the disease. In those with established Type 2 diabetes, there is emerging evidence from cross-sectional studies that sleep disturbance affects glycemic control. Although cross-sectional studies suggest a relationship between sleep disturbance and glycemic control in Type 2 diabetes, causality is best investigated by interventional studies. Suvorexant has a comparatively benign side effect profile compared to many of the hypnotic agents typically prescribed for insomnia. The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST), as well as subjective wake after sleep onset, Insomnia Severity Index, HbA1c levels and insulin sensitivity, inflammatory markers, and other subjective sleep endpoints.

Conditions

Type 2 Diabetes Mellitus; Insomnia; Sleep Disorder; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

Group Type: ACTIVE_COMPARATOR

Suvorexant

Intervention Type: DRUG

10-mg or 20-mg Suvorexant capsules

Placebo Responders

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo capsules

Placebo Non-responders Re-randomized to Treatment

Group Type: ACTIVE_COMPARATOR

Suvorexant

Intervention Type: DRUG

10-mg or 20-mg Suvorexant capsules

Placebo

Intervention Type: OTHER

Matching placebo capsules

Placebo Non-responders Re-randomized to Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo capsules

Interventions

Suvorexant

10-mg or 20-mg Suvorexant capsules

Intervention Type: DRUG

Placebo

Matching placebo capsules

Intervention Type: OTHER

Other Intervention Names

Belsomra

Eligibility Criteria

Inclusion Criteria

1. Men or women of any ethnic origin

2. Written informed consent is obtained

3. Speaks and writes in English

4. A willingness and ability to comply with study procedures.

5. Age 25-75 years

6. 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

7. No changes in diabetes medication in the previous month

8. DSM-5 criteria for Insomnia Disorder

9. Score on the Insomnia Severity Index (ISI) measure >10, indicating at least a moderate level of insomnia symptoms2

10. 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

1. Sleep and medical factors:

1. 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)

2. Shift workers

3. Use of hypnotic medications more than twice per week in the past month

4. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period

5. Unwillingness to maintain stable diabetes medication during the study unless medically indicated

6. Positive urine toxic screen for any drugs of abuse other than marijuana at Screening Visit

7. HbA1c ≥ 10.0% at either the screening or randomization visit

2. Psychiatric factors:

1. Current major depressive episode, by report and as indicated by the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR).

2. Subjects with active or unstable major psychiatric disorder, who, in the investigator's judgement, require further treatment.

3. Current alcohol/substance use disorder

3. Medical factors:

1. Renal or hepatic disease judged to interfere with drug metabolism and excretion

2. Pregnant or breastfeeding

3. Malignancy within past 2 years

4. Surgery within past 3 months

5. 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

6. Medical instability considered to interfere with study procedures

7. Concomitant medications with drug interaction or co-administration concerns

8. Contraindications or allergic responses to suvorexant

9. History of being treated with suvorexant

4. Lifestyle and other factors:

1. Travel across two time-zones during the week prior to enrollment

2. Greater than 6 cups of coffee per day

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Winkelman, MD, PhD

Chief, Sleep Disorders Clinical Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John W Winkelman, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019P000076

Identifier Type: -

Identifier Source: org_study_id