parallel randomized trial
Ellipse™
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide flexible dose injection once daily Liraglutide 1.8 mg or maximum tolerated dose | metformin with or without basal insulin; lifestyle: not reported | 66 | 66 | 56 |
| A2 | Placebo Placebo | metformin with or without basal insulin; lifestyle: not reported | 69 | 68 | 53 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide flexible dose injection once daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 14.6 | 14.6 |
| age | sd (years) | 1.7 | 1.7 |
| asian | n | 10 | 8 |
| asian | percent | 15.2 | 11.8 |
| black | n | 9 | 7 |
| black | percent | 13.6 | 10.3 |
| bmi | mean (kg/m2) | 34.6 | 33.3 |
| bmi | sd (kg/m2) | 10.9 | 7.4 |
| diabetes duration | mean (years) | 1.9 | 1.9 |
| diabetes duration | sd (years) | 1.7 | 1.3 |
| female | n | 41 | 42 |
| hba1c | mean (percent) | 7.9 | 7.7 |
| hba1c | sd (percent) | 1.4 | 1.3 |
| hispanic | n | 16 | 23 |
| insulin use | n | 15 | 10 |
| insulin use | percent | 22.7 | 14.7 |
| other race american indian alaska native | n | 2 | 1 |
| other race american indian alaska native | percent | 3.0 | 1.5 |
| other race multiple | n | 0 | 0 |
| other race native hawaiian pacific islander | n | 0 | 0 |
| other race native hawaiian pacific islander | percent | 0.0 | 0.0 |
| other race other | n | 3 | 7 |
| other race other | percent | 4.5 | 10.3 |
| waist | mean (cm) | 106.1 | 104.3 |
| waist | sd (cm) | 20.7 | 15.0 |
| white | n | 42 | 45 |
| white | percent | 63.6 | 66.2 |
Analyses this trial contributes to
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 12 to 40 (target week 26); descriptive only
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 40 to 64 (target week 52); descriptive only
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 40 to 64 (target week 52); descriptive only
- HbA1c changeChildren and adolescents with type 2 diabetes; weeks 12 to 40 (target week 26); descriptive only
- Serious adverse eventsChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- Serious adverse eventsChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- NauseaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- VomitingChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- VomitingChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- DiarrheaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- DiarrheaChildren and adolescents with type 2 diabetes; longest follow-up; network meta-analysis
- ConstipationChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
- ConstipationChildren and adolescents with type 2 diabetes; longest follow-up; descriptive only
Results
21 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (5 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.643 percent | 0.215 | 66 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A2 | md | -1.058 percent | 0.304 | -1.653 to -0.464 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.415 percent | 0.216 | 68 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.732 percent | 1.423 | 56 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 0.677 percent | 1.523 | 52 | treatment policy; 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 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 4 / 68 | while on treatment; safety; registry:adverse_events |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 66 | not stated; randomized; registry:flow | ||||
| A2 | events | 1 / 69 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 19 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 9 / 68 | while on treatment; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 6 / 68 | while on treatment; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 15 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 1 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 11 / 68 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 0 / 68 | while on treatment; safety; registry:adverse_events |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A1 | events | 0 / 66 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 1 / 68 | while on treatment; safety; registry:adverse_events | ||||
| A2 | events | 0 / 68 | while on treatment; safety; registry:adverse_events |