parallel randomized trial
NCT02953665
A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability Liraglutide 1.2 or 1.8 mg as tolerated | lifestyle: not reported | 42 | 33 | |
| A2 | Placebo Placebo | lifestyle: not reported | 21 | 18 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability A1 | Placebo A2 |
|---|---|---|---|
| age: 40 to 49 | n | 5 | 0 |
| age: 50 to 59 | n | 5 | 8 |
| age: 60 to 69 | n | 21 | 9 |
| age: 70 or older | n | 11 | 4 |
| age | mean (years) | 63.5 | 64.2 |
| age | sd (years) | 9.8 | 6.4 |
| asian | n | 0 | 1 |
| black | n | 0 | 1 |
| female | n | 13 | 6 |
| hispanic | n | 2 | 0 |
| other pd symptom duration | mean (years) | 5.3 | 4.9 |
| other pd symptom duration | sd (years) | 3.7 | 3.2 |
| other race american indian alaska native | n | 0 | 0 |
| other race multiple | n | 0 | 0 |
| other race native hawaiian pacific islander | n | 0 | 0 |
| white | n | 42 | 19 |
Analyses this trial contributes to
- Motor function (Parkinson disease)Parkinson disease; weeks 36 to 78 (target week 52); descriptive only
- Motor function (Parkinson disease)Parkinson disease; weeks 36 to 78 (target week 52); descriptive only
- Serious adverse eventsParkinson disease; longest follow-up; descriptive only
- Serious adverse eventsParkinson disease; longest follow-up; descriptive only
- NauseaParkinson disease; longest follow-up; descriptive only
- NauseaParkinson disease; longest follow-up; descriptive only
- VomitingParkinson disease; longest follow-up; descriptive only
- VomitingParkinson disease; longest follow-up; descriptive only
- DiarrheaParkinson disease; longest follow-up; descriptive only
- DiarrheaParkinson disease; longest follow-up; descriptive only
- ConstipationParkinson disease; longest follow-up; descriptive only
- ConstipationParkinson disease; longest follow-up; descriptive only
Results
16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Motor function (Parkinson disease) (2 lines; O101)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 54 | A1 | change | -2.3 points | 9.4 | 33 | not stated; full analysis; registry:outcomes | |
| 54 | A2 | change | -5.0 points | 7.1 | 18 | not stated; full analysis; registry:outcomes |
Acute kidney injury (2 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Health related quality of life total score (any instrument) (2 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 54 | A1 | change | -2.5 points | 9.9 | 33 | not stated; full analysis; registry:outcomes | |
| 54 | A2 | change | 11.2 points | 14.0 | 18 | not stated; full analysis; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 21 | not stated; safety; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 24 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 21 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 21 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 42 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 21 | not stated; safety; registry:adverse_events |