parallel randomized trial

NCT00781937

Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period

Overweight or obesity without diabetes (adults)NCT00781937S001278

Design

Randomized: 422
Start year: 2008
Treatment: 56 weeks, follow-up 68 weeks
Countries: United States, Canada
Sponsor: Novo Nordisk A/S (industry)
Eligibility: BMI 30 or more or 27 with comorbidity; no diabetes; at least 5 percent loss on run in

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: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Lira 3.0 mg	standard energy restricted diet; lifestyle: standard	212	194	159
A2	Placebo Placebo	energy restricted diet; lifestyle: standard	210	188	146

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)	45.9	46.5
age	sd (years)	11.9	11.0
asian	n	1	0
black	n	32	24
bmi	mean (kg/m2)	36.0	35.2
bmi	sd (kg/m2)	5.9	5.9
female	n	178	165
hispanic	n	17	11
other bmi screening	mean (kg/m2)	38.2	37.5
other bmi screening	sd (kg/m2)	6.2	6.2
other comorbidity	n	94	96
other race native hawaiian pacific islander	n	2	0
other race unknown	n	7	1
other weight screening	mean (kg)	106.7	105.0
other weight screening	sd (kg)	21.8	22.4
weight	mean (kg)	100.4	98.7
weight	sd (kg)	20.8	21.2
white	n	170	185

Analyses this trial contributes to

Results

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

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	1.31 mmHg	0.90		207	not stated; full analysis; registry:outcomes
56	A1 vs A2	md	-2.72 mmHg		-4.69 to -0.76		not stated; full analysis; registry:outcomes
56	A2	change	4.03 mmHg	0.87		206	not stated; full analysis; registry:outcomes

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	percent change	-6.26 percent			194	not stated; full analysis; R0013170:Supplement Table S3
56	A1	percent change	-6.11 percent	0.66		194	not stated; full analysis; registry:outcomes
56	A1 vs A2	md	-6.06 percent		-7.50 to -4.62		not stated; full analysis; registry:outcomes
56	A2	percent change	-0.20 percent			188	not stated; full analysis; R0013170:Supplement Table S3
56	A2	percent change	-0.05 percent	0.63		188	not stated; full analysis; registry:outcomes

Weight loss of 5 percent or more (6 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1	responders	50.7		194	not stated; full analysis; R0013170:Supplement Table S3
56	A1	responders	50.5		194	not stated; full analysis; registry:outcomes
56	A1 vs A2	or	3.81	2.42 to 5.99		not stated; full analysis; R0013170:Supplement Table S3
56	A1 vs A2	or	3.86	2.44 to 6.09		not stated; full analysis; registry:outcomes
56	A2	responders	21.3		188	not stated; full analysis; R0013170:Supplement Table S3
56	A2	responders	21.9		188	not stated; full analysis; registry:outcomes

Weight loss of 10 percent or more (6 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1	responders	27.4		194	not stated; full analysis; R0013170:Supplement Table S3
56	A1	responders	26.1		194	not stated; full analysis; registry:outcomes
56	A1 vs A2	or	5.14	2.72 to 9.71		not stated; full analysis; R0013170:Supplement Table S3
56	A1 vs A2	or	5.30	2.79 to 10.08		not stated; full analysis; registry:outcomes
56	A2	responders	6.8		188	not stated; full analysis; R0013170:Supplement Table S3
56	A2	responders	6.3		188	not stated; full analysis; registry:outcomes

Three point MACE (2 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; safety; R0013170:Table 1
	A2	events				1 /	not stated; safety; R0013170:Table 1

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 212	not stated; safety; cardiac failure; registry:adverse_events
	A2	events				1 / 210	not stated; safety; cardiac failure; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 212	not stated; safety; registry:adverse_events
	A2	events				5 / 210	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 212	not stated; randomized; registry:flow
	A2	events				18 / 210	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				101 / 212	not stated; safety; registry:adverse_events
	A2	events				36 / 210	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				35 / 212	not stated; safety; registry:adverse_events
	A2	events				5 / 210	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				38 / 212	not stated; safety; registry:adverse_events
	A2	events				26 / 210	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				57 / 212	not stated; safety; registry:adverse_events
	A2	events				26 / 210	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 212	not stated; safety; cholelithiasis; registry:adverse_events
	A2	events				0 / 210	not stated; safety; cholelithiasis; registry:adverse_events

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 212	not stated; safety; registry:adverse_events
	A2	events				0 / 210	not stated; safety; registry:adverse_events