parallel randomized trial
NCT04186494
The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 3.0 mg subcutaneous once daily Liraglutide based weight loss regimen | lifestyle: standard | 10 | 10 | |
| A2 | Cpap CPAP | lifestyle: not reported | 10 | 11 | |
| A3 | liraglutide and CPAP CPAP plus liraglutide | lifestyle: standard | 10 | 9 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 3.0 mg subcutaneous once daily A1 | Cpap A2 | CPAP plus liraglutide A3 |
|---|---|---|---|---|
| age | mean (years) | 50 | 51 | 50 |
| age | sd (years) | 9 | 8 | 5 |
| ahi | mean (events/h) | 53 | 50 | 47 |
| ahi | sd (events/h) | 20 | 21 | 16 |
| bmi | mean (kg/m2) | 35.0 | 36.0 | 34.0 |
| bmi | sd (kg/m2) | 3.1 | 3.2 | 3.3 |
| female | n | 2 | 1 | 3 |
| female | percent | 20 | 10 | 30 |
| hba1c | mean (mmol/mol) | 38.4 | 37.8 | 39.0 |
| hba1c | sd (mmol/mol) | 3.9 | 2.6 | 3.1 |
| sbp | mean (mmHg) | 126 | 119 | 120 |
| sbp | sd (mmHg) | 13 | 10 | 12 |
| waist group:as_treated | mean (cm) | 119 | 122 | 117 |
| waist group:as_treated | sd (cm) | 9 | 10 | 11 |
| weight group:as_treated | mean (kg) | 107 | 108 | 104 |
| weight group:as_treated | sd (kg) | 14 | 10 | 13 |
Results
16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Systolic blood pressure change (3 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -5.51 mmHg | 6.32 | 10 | not stated; other; group:as_treated; R0025517:Table 2 | |
| 24 | A2 | change | 0.88 mmHg | 5.91 | 11 | not stated; other; group:as_treated; R0025517:Table 2 | |
| 24 | A3 | change | -2.33 mmHg | 11.66 | 9 | not stated; other; group:as_treated; R0025517:Table 2 |
Percent body weight change (3 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | percent change | -6 percent | 10 | not stated; other; group:as_treated; R0025517:Results | ||
| 24 | A2 | percent change | 2 percent | 11 | not stated; other; group:as_treated; R0025517:Results | ||
| 24 | A3 | percent change | -4 percent | 9 | not stated; other; group:as_treated; R0025517:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 10 | not stated; randomized; R0025517:Results | ||||
| A3 | events | 1 / 10 | not stated; randomized; R0025517:Results |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 10 | not stated; randomized; R0025517:Results | ||||
| A3 | events | 1 / 10 | not stated; randomized; R0025517:Results |
Apnea hypopnea index change (6 lines; O70)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -12 events/h | 10 | not stated; other; group:as_treated; R0025517:Abstract | ||
| 24 | A1 | final | 42 events/h | 10 | not stated; other; group:as_treated; R0025517:Table 3 | ||
| 24 | A2 | change | -45 events/h | 11 | not stated; other; group:as_treated; R0025517:Abstract | ||
| 24 | A2 | final | 3 events/h | 11 | not stated; other; group:as_treated; R0025517:Table 3 | ||
| 24 | A3 | change | -43 events/h | 9 | not stated; other; group:as_treated; R0025517:Abstract | ||
| 24 | A3 | final | 5 events/h | 9 | not stated; other; group:as_treated; R0025517:Table 3 |