parallel randomized trial
NCT02496611
Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo plus lifestyle therapy | lifestyle therapy after meal replacement induction; lifestyle: not reported | 33 | 33 | |
| A2 | Exenatide extended release 2 mg subcutaneous once weekly Exenatide extended release 2 mg weekly plus lifestyle therapy | lifestyle therapy after meal replacement induction; lifestyle: not reported | 33 | 33 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Exenatide extended release 2 mg subcutaneous once weekly A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 16 | ||
| age | sd (years) | 1.5 | ||
| bmi | mean (kg/m2) | 36.9 | ||
| bmi | sd (kg/m2) | 4.4 | ||
| female | n | 13 | 18 | |
| hispanic | n | 2 | 5 |
Analyses this trial contributes to
- Percent BMI changeChildren and adolescents with obesity; weeks 40 to 104 (target week 68); network meta-analysis
- Percent BMI changeChildren and adolescents with obesity; weeks 40 to 104 (target week 68); network meta-analysis
- Serious adverse eventsChildren and adolescents with obesity; longest follow-up; network meta-analysis
- Serious adverse eventsChildren and adolescents with obesity; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with obesity; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with obesity; longest follow-up; network meta-analysis
- VomitingChildren and adolescents with obesity; longest follow-up; network meta-analysis
- VomitingChildren and adolescents with obesity; longest follow-up; network meta-analysis
- DiarrheaChildren and adolescents with obesity; longest follow-up; network meta-analysis
- DiarrheaChildren and adolescents with obesity; longest follow-up; network meta-analysis
- ConstipationChildren and adolescents with obesity; longest follow-up; network meta-analysis
- ConstipationChildren and adolescents with obesity; longest follow-up; network meta-analysis
Results
16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent BMI change (4 lines; O13B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | percent change | 10.1 percent | 9.0 | 33 | not stated; randomized; registry:outcomes | |
| 52 | A2 | percent change | 4.6 percent | 10.5 | 33 | not stated; randomized; registry:outcomes | |
| 52 | A2 vs A1 | md | -4.1 percent | -8.6 to 0.5 | not stated; randomized; R0009976:Abstract | ||
| 52 | A2 vs A1 | md | -5.7 percent | -10.9 to -0.6 | not stated; per protocol; R0009976:Abstract |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 0 / 33 | not stated; randomized; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 1 / 33 | not stated; randomized; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 13 / 33 | not stated; randomized; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 13 / 33 | not stated; randomized; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 11 / 33 | not stated; randomized; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 33 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 6 / 33 | not stated; randomized; registry:adverse_events |