crossover randomized trial

NCT00978393

A Randomised, Placebo-controlled, Double-blind, Incomplete Cross-over Design Trial to Evaluate the Effects of Liraglutide on Gastric Emptying, Energy Expenditure and Appetite, and to Evaluate Liraglutide Pharmacokinetics in Non-diabetic Obese Subjects

Overweight or obesity without diabetes (adults)NCT00978393S001351

Design

Randomized: 49
Start year: 2009
Treatment: 5 weeks
Countries: Netherlands (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 75; BMI 30 to 40; fasting glucose below 7.0 mmol/L; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: mixed model on observed data

Arms

Arm	Treatment	Background	Analyzed
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle: none	30
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: none	30
A3	Placebo Placebo	lifestyle: none	30

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	48.3
age	sd (years)	13.2
bmi	mean (kg/m2)	34.2
bmi	sd (kg/m2)	2.7
female	n	20
other fasting glucose	mean (mmol/L)	5.4
other fasting glucose	sd (mmol/L)	0.55
other fat mass	mean (percent)	33.1
other fat mass	sd (percent)	7.1
weight	mean (kg)	102.0
weight	sd (kg)	13.9

Results

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

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 30	not stated; safety; R0024592:Results
A2	events	1 / 32	not stated; safety; R0024592:Results
A3	events	0 / 32	not stated; safety; R0024592:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	11 / 30	not stated; safety; R0024592:Supplement Table S3
A2	events	9 / 32	not stated; safety; R0024592:Supplement Table S3
A3	events	3 / 32	not stated; safety; R0024592:Supplement Table S3

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 30	not stated; safety; R0024592:Supplement Table S3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	6 / 30	not stated; safety; R0024592:Supplement Table S3
A2	events	9 / 32	not stated; safety; R0024592:Supplement Table S3
A3	events	3 / 32	not stated; safety; R0024592:Supplement Table S3

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 30	not stated; safety; R0024592:Supplement Table S3
A2	events	3 / 32	not stated; safety; R0024592:Supplement Table S3
A3	events	1 / 32	not stated; safety; R0024592:Supplement Table S3