crossover randomized trial

NCT02944500

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Saxenda: Underlying Mechanisms and Clinical Outcomes

Overweight or obesity without diabetes (adults)NCT02944500S001466

Design

Randomized: 28
Start year: 2016
Treatment: 5 weeks
Countries: USA (1 sites)
Sponsor: Beth Israel Deaconess Medical Center (mixed)
Eligibility: BMI above 30, or above 27 with comorbidity; diabetes not excluded; no oral glucose lowering drug except metformin

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: while on treatment
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: standard	28	20
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg	lifestyle: standard	28	20

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Liraglutide 3.0 mg subcutaneous once daily A2
bmi	mean (kg/m2)	35.1	35.5

Results

10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 20	while on treatment; completers; R0024373:Supplement Table S1
A1	events	0 / 20	while on treatment; completers; intolerable nausea; R0024373:Supplement Table S1
A2	events	3 / 20	while on treatment; completers; R0024373:Supplement Table S1
A2	events	0 / 20	while on treatment; completers; intolerable nausea; R0024373:Supplement Table S1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	while on treatment; completers; R0024373:Supplement Table S1
	A2	events				0 / 20	while on treatment; completers; R0024373:Supplement Table S1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	while on treatment; completers; R0024373:Supplement Table S1
	A2	events				0 / 20	while on treatment; completers; R0024373:Supplement Table S1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	while on treatment; completers; R0024373:Supplement Table S1
	A2	events				2 / 20	while on treatment; completers; R0024373:Supplement Table S1