parallel randomized trial

NCT01557166

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial

Overweight or obesity without diabetes (adults)Obstructive sleep apnea NCT01557166S002315

Design

Randomized: 359
Start year: 2012
Treatment: 32 weeks
Countries: United States, Canada (40 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 64; BMI 30 or more; AHI 15 or more; no diabetes; unable or unwilling to use CPAP

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	500 kcal deficit diet and 150 min weekly activity advice; lifestyle: standard	180	180
A2	Placebo Placebo	500 kcal deficit diet and 150 min weekly activity advice; lifestyle: standard	179	179

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	48.6	48.4
age	sd (years)	9.9	9.5
ahi: 15 to 29.9	n	60	58
ahi: 15 to 29.9	percent	33.3	32.4
ahi: 30 or more	n	120	121
ahi: 30 or more	percent	66.7	67.6
ahi	mean (events/h)	49.0	49.3
ahi	sd (events/h)	27.5	27.5
asian	n	13	3
asian	percent	7.2	1.7
black	n	33	36
black	percent	18.3	20.1
bmi: 27 to 29.9	n	0	1
bmi: 27 to 29.9	percent		0.6
bmi: 30 to 34.9	n	58	51
bmi: 30 to 34.9	percent	32.2	28.5
bmi: 35 to 39.9	n	59	62
bmi: 35 to 39.9	percent	32.8	34.6
bmi: 40 or more	n	63	65
bmi: 40 or more	percent	35.0	36.3
bmi	mean (kg/m2)	38.9	39.4
bmi	sd (kg/m2)	6.4	7.4
female	n	51	50
female	percent	28.3	27.9
hba1c	mean (percent)	5.7	5.6
hba1c	sd (percent)	0.4	0.4
hispanic	n	19	24
hispanic	percent	10.6	13.4
other race native hawaiian pacific islander	n	1	2
other race native hawaiian pacific islander	percent	0.6	1.1
other race other	n	3	3
other race other	percent	1.7	1.7
waist	mean (cm)	122.3	122.7
waist	sd (cm)	14.5	14.9
weight	mean (kg)	116.5	118.7
weight	sd (kg)	23.0	25.4
white	n	130	135
white	percent	72.2	75.4

Analyses this trial contributes to

Results

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

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	percent change	-5.73 percent			175	not stated; full analysis; R0013170:Supplement Table S3
32	A1	percent change	-5.7 percent	0.4			not stated; full analysis; R0026203:Results
32	A1 vs A2	md	-4.2 percent		-5.2 to -3.1		not stated; full analysis; R0026203:Results
32	A2	percent change	-1.58 percent			178	not stated; full analysis; R0013170:Supplement Table S3
32	A2	percent change	-1.6 percent	0.3			not stated; full analysis; R0026203:Results

Weight loss of 5 percent or more (5 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
32	A1	responders	46.4		175	not stated; full analysis; R0013170:Supplement Table S3
32	A1	responders	46.3		180	not stated; full analysis; R0026203:Results
32	A1 vs A2	or	3.9	2.4 to 6.4		not stated; full analysis; R0026203:Results
32	A2	responders	18.1		178	not stated; full analysis; R0013170:Supplement Table S3
32	A2	responders	18.5		179	not stated; full analysis; R0026203:Results

Weight loss of 10 percent or more (5 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
32	A1	responders	22.4		175	not stated; full analysis; R0013170:Supplement Table S3
32	A1	responders	23.4		180	not stated; full analysis; R0026203:Results
32	A1 vs A2	or	19.0	5.7 to 63.1		not stated; full analysis; R0026203:Results
32	A2	responders	1.5		178	not stated; full analysis; R0013170:Supplement Table S3
32	A2	responders	1.7		179	not stated; full analysis; R0026203:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	while on treatment; safety; R0026203:Results
	A2	events				0 / 179	while on treatment; safety; R0026203:Results

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	while on treatment; other; R0013170:Table 1
	A2	events				2 /	while on treatment; other; R0013170:Table 1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 176	while on treatment; safety; R0026203:Table 2
	A2	events				6 / 179	while on treatment; safety; R0026203:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	12	180	not stated; randomized; R0026203:Results
A1	events		20 / 180	not stated; randomized; registry:flow
A2	events	3	179	not stated; randomized; R0026203:Results
A2	events		6 / 179	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				47 / 176	while on treatment; safety; R0026203:Table 2
	A2	events				12 / 179	while on treatment; safety; R0026203:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 176	while on treatment; safety; R0026203:Table 2
	A2	events				5 / 179	while on treatment; safety; R0026203:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 176	while on treatment; safety; R0026203:Table 2
	A2	events				14 / 179	while on treatment; safety; R0026203:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				21 / 176	while on treatment; safety; R0026203:Table 2
	A2	events				6 / 179	while on treatment; safety; R0026203:Table 2

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 176	while on treatment; safety; cholecystitis; R0026203:Table 2
A1	events	1 / 176	while on treatment; safety; cholelithiasis; R0026203:Table 2
A2	events	1 / 179	while on treatment; safety; cholecystitis; R0026203:Table 2
A2	events	0 / 179	while on treatment; safety; cholelithiasis; R0026203:Table 2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	while on treatment; safety; R0026203:Results
	A2	events				0 / 179	while on treatment; safety; R0026203:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	while on treatment; safety; R0026203:Results
	A2	events				0 / 179	while on treatment; safety; R0026203:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 176	while on treatment; safety; depression suicidal; R0026203:Table 2
	A2	events				0 / 179	while on treatment; safety; depression suicidal; R0026203:Table 2

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 176	while on treatment; safety; R0026203:Results
	A2	events				0 / 179	while on treatment; safety; R0026203:Results

Apnea hypopnea index change (5 lines; O70)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	change	-12.2 events/h	1.8			not stated; full analysis; R0026203:Results
32	A1	change	-12.22 events/hour	23.34		168	not stated; full analysis; registry:outcomes
32	A1 vs A2	md	-6.1 events/h		-11.0 to -1.2		not stated; full analysis; R0026203:Results
32	A2	change	-6.1 events/h	2.0			not stated; full analysis; R0026203:Results
32	A2	change	-6.08 events/hour	25.90		166	not stated; full analysis; registry:outcomes