parallel randomized trial
NCT02696148
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide maximum tolerated dose injection once daily Liraglutide up to 3.0 mg QD or maximum tolerated | lifestyle: not reported | 16 | 16 | |
| A2 | Placebo Placebo QD | lifestyle: not reported | 8 | 8 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide maximum tolerated dose injection once daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 9.7 | 10.4 |
| age | sd (years) | 1.1 | 1.1 |
| black | n | 7 | 3 |
| black | percent | 43.8 | 37.5 |
| bmi sds | mean (SDS) | 3.8 | 4.1 |
| bmi sds | sd (SDS) | 0.9 | 1.0 |
| female | n | 8 | 1 |
| female | percent | 50.0 | 12.5 |
| hba1c | mean (percent) | 5.5 | 5.4 |
| hba1c | sd (percent) | 0.4 | 0.4 |
| hispanic | n | 6 | 3 |
| hispanic | percent | 37.5 | 37.5 |
| weight | mean (kg) | 66.6 | 81.4 |
| weight | sd (kg) | 12.6 | 16.6 |
| white | n | 9 | 5 |
| white | percent | 56.3 | 62.5 |
Analyses this trial contributes to
- 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
- Discontinuation due to adverse eventsChildren and adolescents with obesity; longest follow-up; descriptive only
- Discontinuation due to adverse eventsChildren and adolescents with obesity; longest follow-up; descriptive only
- 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
Results
13 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
BMI standard deviation score change (3 lines; O13A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 8 | A1 | change | -0.3 SDS | 16 | not stated; safety; R0024666:Results | ||
| 8 | A1 vs A2 | md | -0.28 SDS | -0.47 to -0.09 | not stated; safety; R0024666:Results | ||
| 8 | A2 | change | -0.01 SDS | 8 | not stated; safety; R0024666:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 16 | not stated; safety; R0024666:Results | ||||
| A2 | events | 0 / 8 | not stated; safety; R0024666:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 16 | not stated; safety; R0024666:Results | ||||
| A2 | events | 0 / 8 | not stated; safety; R0024666:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 16 | not stated; safety; R0024666:Supplement Table S3 | ||||
| A2 | events | 0 / 8 | not stated; safety; R0024666:Supplement Table S3 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 16 | not stated; safety; R0024666:Supplement Table S3 | ||||
| A2 | events | 0 / 8 | not stated; safety; R0024666:Supplement Table S3 |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 16 | not stated; safety; R0024666:Supplement Table S3 | ||||
| A2 | events | 0 / 8 | not stated; safety; R0024666:Supplement Table S3 |