crossover randomized trial

NCT02079870

A Single-centre, Randomised, Double-blind Two-period Cross-over Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

Overweight or obesity without diabetes (adults)NCT02079870S001635

Design

Randomized: 30
Start year: 2014
Treatment: 12 weeks
Countries: (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or more; BMI 30 to 45; HbA1c below 6.5 percent; 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: linear mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: not reported	30	28
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	lifestyle: not reported	30	30

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	max (years)	70
age	mean (years)	42
age	min (years)	21
age	sd (years)	11
black	n	3
black	percent	10.0
bmi	max (kg/m2)	42.8
bmi	mean (kg/m2)	33.8
bmi	min (kg/m2)	30.5
bmi	sd (kg/m2)	2.5
female	n	10
female	percent	33.3
weight	max (kg)	121.2
weight	mean (kg)	101.3
weight	min (kg)	81.5
weight	sd (kg)	10.5
white	n	27
white	percent	90.0

Results

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

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				0 / 30	not stated; full analysis; R0025356:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				0 / 30	not stated; full analysis; R0025356:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				0 / 30	not stated; full analysis; R0025356:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				2 / 30	not stated; full analysis; R0025356:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				2 / 30	not stated; full analysis; R0025356:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; full analysis; R0025356:Results
	A2	events				0 / 30	not stated; full analysis; R0025356:Results