LivingGLP1
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

Randomized
135
Start year
2012
Treatment
52 weeks, follow-up 52 weeks
Countries
multinational (84 sites)
Sponsor
Novo Nordisk A/S (industry)
Eligibility
age 10 to under 17; BMI above 85th percentile; HbA1c 7.0 to 11.0 (6.5 to 11.0 if treated)

Conduct and analysis

Blinding
double blind
Sequence generation
not reported
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
treatment policy
Analysis population
full analysis
Missing data
pattern mixture model multiple imputation

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Liraglutide flexible dose injection once daily
Liraglutide 1.8 mg or maximum tolerated dose
metformin with or without basal insulin; lifestyle: not reported666656
A2Placebo
Placebo
metformin with or without basal insulin; lifestyle: not reported696853

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticLiraglutide flexible dose injection once daily
A1
Placebo
A2
agemean (years)14.614.6
agesd (years)1.71.7
asiann108
asianpercent15.211.8
blackn97
blackpercent13.610.3
bmimean (kg/m2)34.633.3
bmisd (kg/m2)10.97.4
diabetes durationmean (years)1.91.9
diabetes durationsd (years)1.71.3
femalen4142
hba1cmean (percent)7.97.7
hba1csd (percent)1.41.3
hispanicn1623
insulin usen1510
insulin usepercent22.714.7
other race american indian alaska nativen21
other race american indian alaska nativepercent3.01.5
other race multiplen00
other race native hawaiian pacific islandern00
other race native hawaiian pacific islanderpercent0.00.0
other race othern37
other race otherpercent4.510.3
waistmean (cm)106.1104.3
waistsd (cm)20.715.0
whiten4245
whitepercent63.666.2

Analyses this trial contributes to

Results

21 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (5 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26A1change-0.643 percent0.21566treatment policy; full analysis; registry:outcomes
26A1 vs A2md-1.058 percent0.304-1.653 to -0.464treatment policy; full analysis; registry:outcomes
26A2change0.415 percent0.21668treatment policy; full analysis; registry:outcomes
52A1change-0.732 percent1.42356treatment policy; full analysis; registry:outcomes
52A2change0.677 percent1.52352treatment policy; full analysis; registry:outcomes
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events9 / 66while on treatment; safety; registry:adverse_events
A2events4 / 68while on treatment; safety; registry:adverse_events
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 66not stated; randomized; registry:flow
A2events1 / 69not stated; randomized; registry:flow
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events19 / 66while on treatment; safety; registry:adverse_events
A2events9 / 68while on treatment; safety; registry:adverse_events
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events17 / 66while on treatment; safety; registry:adverse_events
A2events6 / 68while on treatment; safety; registry:adverse_events
Diarrhea (4 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events15 / 66while on treatment; safety; registry:adverse_events
A1events1 / 66while on treatment; safety; registry:adverse_events
A2events11 / 68while on treatment; safety; registry:adverse_events
A2events0 / 68while on treatment; safety; registry:adverse_events
Constipation (4 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events4 / 66while on treatment; safety; registry:adverse_events
A1events0 / 66while on treatment; safety; registry:adverse_events
A2events1 / 68while on treatment; safety; registry:adverse_events
A2events0 / 68while on treatment; safety; registry:adverse_events