Trial Outcomes & Findings for Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes (NCT NCT03818581)
NCT ID: NCT03818581
Last Updated: 2024-08-20
Results Overview
Total sleep time as reported on daily sleep diaries
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
2 weeks
Results posted on
2024-08-20
Participant Flow
108 participants were enrolled. 36 participants did not meet the eligibility criteria post-enrollment, and thus were not randomized. 3 additional participants were removed from the study prior to randomization due to protocol non-adherence. So, a total of 39 participants who were enrolled were not randomized to the study. 69 participants were randomized, but 2 of them were not treated, leaving a total of 67 participants who were treated.
Participant milestones
| Measure |
Treatment Group
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Responders
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
Suvorexant capsules: 10-mg or 20-mg
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Placebo
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
Placebo
Discontinued or withdrew before randomization 2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
7
|
16
|
18
|
3
|
|
Overall Study
COMPLETED
|
20
|
7
|
16
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Treatment Group
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Responders
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
Suvorexant capsules: 10-mg or 20-mg
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Placebo
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
Placebo
Discontinued or withdrew before randomization 2
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Covid-19
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
No longer met study criteria
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Treatment Group
n=20 Participants
Suvorexant: 10-mg or 20-mg Suvorexant capsules
|
Placebo Responders
n=7 Participants
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
n=16 Participants
Suvorexant: 10-mg or 20-mg Suvorexant capsules
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Placebo
n=18 Participants
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
60.6 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
58.3 years
STANDARD_DEVIATION 10.1 • n=157 Participants
|
60.5 years
STANDARD_DEVIATION 8.8 • n=390 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
42 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
19 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
16 Participants
n=157 Participants
|
56 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
55 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Subjective Total Sleep Time
|
5.5 Hours
STANDARD_DEVIATION 0.7 • n=99 Participants
|
5.6 Hours
STANDARD_DEVIATION 0.9 • n=107 Participants
|
6.3 Hours
STANDARD_DEVIATION 0.7 • n=206 Participants
|
6.1 Hours
STANDARD_DEVIATION 0.7 • n=157 Participants
|
5.9 Hours
STANDARD_DEVIATION 0.8 • n=390 Participants
|
|
Insomnia Severity Index
|
14.7 units on a scale
STANDARD_DEVIATION 3.2 • n=99 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 3.6 • n=107 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 3.8 • n=157 Participants
|
16.1 units on a scale
STANDARD_DEVIATION 3.6 • n=390 Participants
|
|
Wake After Sleep Onset
|
88.2 Minutes
STANDARD_DEVIATION 50.7 • n=99 Participants
|
73.8 Minutes
STANDARD_DEVIATION 41.9 • n=107 Participants
|
64.8 Minutes
STANDARD_DEVIATION 42.3 • n=206 Participants
|
73.1 Minutes
STANDARD_DEVIATION 46.7 • n=157 Participants
|
76.1 Minutes
STANDARD_DEVIATION 44.2 • n=390 Participants
|
|
Calculated Total Sleep Time
|
6.0 Hours
STANDARD_DEVIATION 0.8 • n=99 Participants
|
5.6 Hours
STANDARD_DEVIATION 0.9 • n=107 Participants
|
6.4 Hours
STANDARD_DEVIATION 0.7 • n=206 Participants
|
6.2 Hours
STANDARD_DEVIATION 0.7 • n=157 Participants
|
5.9 Hours
STANDARD_DEVIATION 0.8 • n=390 Participants
|
|
Awakenings
|
2.4 Number of Awakenings
STANDARD_DEVIATION 1.0 • n=99 Participants
|
1.5 Number of Awakenings
STANDARD_DEVIATION 0.8 • n=107 Participants
|
2.1 Number of Awakenings
STANDARD_DEVIATION 1.1 • n=206 Participants
|
2.2 Number of Awakenings
STANDARD_DEVIATION 1.2 • n=157 Participants
|
2.1 Number of Awakenings
STANDARD_DEVIATION 0.5 • n=390 Participants
|
|
Pittsburgh Sleep Quality Index
|
1.8 units on a scale
STANDARD_DEVIATION 0.4 • n=99 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 0.8 • n=107 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.5 • n=206 Participants
|
2 units on a scale
STANDARD_DEVIATION 0.7 • n=157 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.6 • n=390 Participants
|
|
Sleep Onset Latency
|
35.1 Minutes
STANDARD_DEVIATION 17.2 • n=99 Participants
|
47.1 Minutes
STANDARD_DEVIATION 33.7 • n=107 Participants
|
34.9 Minutes
STANDARD_DEVIATION 26.5 • n=206 Participants
|
29.0 Minutes
STANDARD_DEVIATION 19.0 • n=157 Participants
|
34.9 Minutes
STANDARD_DEVIATION 22.5 • n=390 Participants
|
|
Sleep Efficiency
|
75.7 % of time sleeping/time in bed
STANDARD_DEVIATION 0.1 • n=99 Participants
|
80.4 % of time sleeping/time in bed
STANDARD_DEVIATION 0.03 • n=107 Participants
|
82.9 % of time sleeping/time in bed
STANDARD_DEVIATION 0.09 • n=206 Participants
|
80.0 % of time sleeping/time in bed
STANDARD_DEVIATION 0.09 • n=157 Participants
|
79.2 % of time sleeping/time in bed
STANDARD_DEVIATION 0.09 • n=390 Participants
|
|
Beck's Depression Inventory
|
8.4 units on a scale
STANDARD_DEVIATION 5.1 • n=99 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 4.6 • n=107 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 8.3 • n=206 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 6.8 • n=157 Participants
|
9.7 units on a scale
STANDARD_DEVIATION 6.4 • n=390 Participants
|
|
Diabetes Quality of Life
|
8.4 units on a scale
STANDARD_DEVIATION 5.1 • n=99 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 4.6 • n=107 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 8.3 • n=206 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 6.8 • n=157 Participants
|
9.7 units on a scale
STANDARD_DEVIATION 6.4 • n=390 Participants
|
|
Diabetes Distress Scale
|
31.9 units on a scale
STANDARD_DEVIATION 13.2 • n=99 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 18.9 • n=107 Participants
|
33 units on a scale
STANDARD_DEVIATION 12.7 • n=206 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 12.4 • n=157 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 13.1 • n=390 Participants
|
|
HbA1c
|
7.7 % of total hemoglobin
STANDARD_DEVIATION 1.0 • n=99 Participants
|
7.5 % of total hemoglobin
STANDARD_DEVIATION 0.9 • n=107 Participants
|
7.5 % of total hemoglobin
STANDARD_DEVIATION 0.9 • n=206 Participants
|
7.7 % of total hemoglobin
STANDARD_DEVIATION 0.7 • n=157 Participants
|
7.6 % of total hemoglobin
STANDARD_DEVIATION 0.8 • n=390 Participants
|
|
CRP
|
6.5 mg/L
STANDARD_DEVIATION 8.9 • n=99 Participants
|
8.2 mg/L
STANDARD_DEVIATION 7.5 • n=107 Participants
|
5.7 mg/L
STANDARD_DEVIATION 8.3 • n=206 Participants
|
6.0 mg/L
STANDARD_DEVIATION 10.2 • n=157 Participants
|
6.4 mg/L
STANDARD_DEVIATION 8.7 • n=390 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Three participants in the placebo group dropped out before any baseline or follow-up data could be collected. An additional 3 participants in the treatment group dropped out and one participant did not complete the sleep diaries, leaving only 19 participants with interpretable data.
Total sleep time as reported on daily sleep diaries
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Responders
n=7 Participants
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
n=15 Participants
Placebo: Matching placebo capsules
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Non-responders Re-randomized to Placebo
n=17 Participants
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
Subjective Total Sleep Time
|
6.4 hours
Standard Deviation 0.8
|
7.0 hours
Standard Deviation 0.9
|
6.7 hours
Standard Deviation 0.8
|
6.7 hours
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Three participants in the placebo group dropped out before any baseline or follow-up data could be collected. An additional 3 participants in the treatment group dropped out and one participant did not complete the sleep diaries, leaving only 19 participants with interpretable data.
Total time awake after sleep onset as reported on daily sleep diaries
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Responders
n=7 Participants
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
n=14 Participants
Placebo: Matching placebo capsules
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Non-responders Re-randomized to Placebo
n=17 Participants
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
Subjective Wake After Sleep Onset
|
62.4 minutes
Standard Deviation 49.6
|
31.4 minutes
Standard Deviation 21.0
|
36.7 minutes
Standard Deviation 25.8
|
48.3 minutes
Standard Deviation 30.6
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Three participants in the placebo group dropped out before any baseline or follow-up data could be collected. An additional 3 participants in the treatment group dropped out and one participant did not complete the sleep diaries, leaving only 19 participants with interpretable data.
A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Responders
n=7 Participants
Placebo: Matching placebo capsules
|
Placebo Non-responders Re-randomized to Treatment
n=15 Participants
Placebo: Matching placebo capsules
Suvorexant capsules: 10-mg or 20-mg
|
Placebo Non-responders Re-randomized to Placebo
n=17 Participants
Placebo: Matching placebo capsules
Placebo: Matching placebo capsules
|
|---|---|---|---|---|
|
Insomnia Severity Index
|
7.1 units on a scale
Standard Deviation 5.0
|
5.6 units on a scale
Standard Deviation 4.1
|
10.9 units on a scale
Standard Deviation 5.7
|
9.1 units on a scale
Standard Deviation 5.4
|
Adverse Events
Phase 1 Suvorexant
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 1 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2 Suvorexant (From Phase 1 Suvorexant)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Suvorexant (From Phase 1 Placebo Non-Responders)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Placebo (From Phase 1 Placebo Non-Responders)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Placebo (From Phase 1 Placebo Responders)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Suvorexant
n=22 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules
This group includes 22 participants randomized to suvorexant for phase 1. One of the 23 randomized participants was not treated, leaving only 22 with AE data.
|
Phase 1 Placebo
n=43 participants at risk
Placebo: Matching placebo capsules
This group includes 43 participants randomized to placebo for phase 1. One of the 44 randomized participants was not treated, leaving only 43 with AE data.
|
Phase 2 Suvorexant (From Phase 1 Suvorexant)
n=20 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules
This group includes 20 phase 1 suvorexant participants who continued on suvorexant for phase 2
|
Phase 2 Suvorexant (From Phase 1 Placebo Non-Responders)
n=16 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules Placebo: Matching placebo capsules
This group includes 16 phase 1 placebo non-responders re-randomized to suvorexant for phase 2.
|
Phase 2 Placebo (From Phase 1 Placebo Non-Responders)
n=18 participants at risk
Placebo: Matching placebo capsules
This group includes 18 phase 1 placebo non-responders re-randomized to placebo for phase 2.
|
Phase 2 Placebo (From Phase 1 Placebo Responders)
n=7 participants at risk
Placebo: Matching placebo capsules
This group includes 7 phase 1 placebo responders who continued on placebo for phase 2.
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Neuropathy
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/43 • 3 months
|
0.00%
0/20 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/7 • 3 months
|
Other adverse events
| Measure |
Phase 1 Suvorexant
n=22 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules
This group includes 22 participants randomized to suvorexant for phase 1. One of the 23 randomized participants was not treated, leaving only 22 with AE data.
|
Phase 1 Placebo
n=43 participants at risk
Placebo: Matching placebo capsules
This group includes 43 participants randomized to placebo for phase 1. One of the 44 randomized participants was not treated, leaving only 43 with AE data.
|
Phase 2 Suvorexant (From Phase 1 Suvorexant)
n=20 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules
This group includes 20 phase 1 suvorexant participants who continued on suvorexant for phase 2
|
Phase 2 Suvorexant (From Phase 1 Placebo Non-Responders)
n=16 participants at risk
Suvorexant: 10-mg or 20-mg Suvorexant capsules Placebo: Matching placebo capsules
This group includes 16 phase 1 placebo non-responders re-randomized to suvorexant for phase 2.
|
Phase 2 Placebo (From Phase 1 Placebo Non-Responders)
n=18 participants at risk
Placebo: Matching placebo capsules
This group includes 18 phase 1 placebo non-responders re-randomized to placebo for phase 2.
|
Phase 2 Placebo (From Phase 1 Placebo Responders)
n=7 participants at risk
Placebo: Matching placebo capsules
This group includes 7 phase 1 placebo responders who continued on placebo for phase 2.
|
|---|---|---|---|---|---|---|
|
General disorders
Grogginess
|
22.7%
5/22 • 3 months
|
2.3%
1/43 • 3 months
|
10.0%
2/20 • 3 months
|
18.8%
3/16 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/7 • 3 months
|
|
General disorders
Vivid dreams
|
13.6%
3/22 • 3 months
|
0.00%
0/43 • 3 months
|
5.0%
1/20 • 3 months
|
18.8%
3/16 • 3 months
|
0.00%
0/18 • 3 months
|
14.3%
1/7 • 3 months
|
|
General disorders
Headache
|
9.1%
2/22 • 3 months
|
2.3%
1/43 • 3 months
|
5.0%
1/20 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/7 • 3 months
|
|
Gastrointestinal disorders
Dry Mouth
|
4.5%
1/22 • 3 months
|
0.00%
0/43 • 3 months
|
10.0%
2/20 • 3 months
|
0.00%
0/16 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/7 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place