Trial Outcomes & Findings for A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks (NCT NCT01832532)
NCT ID: NCT01832532
Last Updated: 2020-10-20
Results Overview
Change in the number of apneas plus hypopnea events per hour of sleep from baseline at end of study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2020-10-20
Participant Flow
Enrollment fell short of goal for each cohort
Participant milestones
| Measure |
Treatment Group- Liraglutide
Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.
liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
|
Control Group
Control group
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
11
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Treatment Group- Liraglutide
Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.
liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
|
Control Group
Control group
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks
Baseline characteristics by cohort
| Measure |
Treatment Group- Liraglutide
n=18 Participants
Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.
liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
|
Control Group
n=9 Participants
Control group
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 8 • n=99 Participants
|
44.5 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
46.2 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
9 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksChange in the number of apneas plus hypopnea events per hour of sleep from baseline at end of study.
Outcome measures
| Measure |
Treatment Group- Liraglutide
n=18 Participants
Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.
liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
|
Control Group
n=9 Participants
Control group
|
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI) From Baseline
|
38.2 apnea / hypopnea events per hour sleep
Standard Deviation 30
|
34 apnea / hypopnea events per hour sleep
Standard Deviation 20
|
Adverse Events
Treatment Group- Liraglutide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raouf Amin, MD
Cincinnati Children's Hospital Medical Center
Phone: (513) 636-7945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place