parallel randomized trial

S003067

Overweight or obesity without diabetes (adults)S003067

Design

Randomized: 564
Start year: 2007
Treatment: 52 weeks, follow-up 52 weeks
Countries: multinational (19 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 to 65; BMI 30 to 40; FPG below 7 mmol/L; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	98	98
A2	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	95	94
A3	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	90	90
A4	Liraglutide 2.4 mg injection once daily Liraglutide 2.4 mg	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	93	92
A5	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	93	92
A6	Orlistat Orlistat 120 mg three times daily	diet with 500 kcal daily deficit and activity advice; lifestyle: standard	95	95

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Liraglutide 1.2 mg subcutaneous once daily A2	Liraglutide 1.8 mg subcutaneous once daily A3	Liraglutide 2.4 mg injection once daily A4	Liraglutide 3.0 mg subcutaneous once daily A5	Orlistat A6
age	mean (years)	45.9	47.2	45.5	45.0	45.9	45.9
age	sd (years)	10.3	9.7	10.9	11.1	10.7	9.1
bmi	mean (kg/m2)	34.9	34.8	35.0	35.0	34.8	34.1
bmi	sd (kg/m2)	2.8	2.6	2.6	2.8	2.8	2.6
female	percent	75	77	76	76	75	77
hba1c	mean (percent)	5.6	5.6	5.6	5.5	5.6	5.6
hba1c	sd (percent)	0.4	0.3	0.4	0.3	0.4	0.3
sbp	mean (mmHg)	124	127	123	126	124	123
sbp	sd (mmHg)	11.1	13.1	13.0	13.9	11.3	13.5
waist	mean (cm)	108	109	108	110	109	108
waist	sd (cm)	10.0	10.4	9.5	10.7	8.3	9.7
weight	mean (kg)	97.3	96.2	98.0	98.4	97.6	96.0
weight	sd (kg)	12.3	13.5	12.5	13.0	13.7	11.7

Analyses this trial contributes to

Results

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

Systolic blood pressure change (28 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Detail
52	A1	change	-1.6 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A1	change	-0.2 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A2	change	-4.2 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A2	change	-3.9 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A2 vs A1	md	-2.4 mmHg	-6.4 to 1.6	not stated; modified itt; R0025439:Supplement Table 3
52	A2 vs A1	md	-3.7 mmHg	-8.1 to 0.8	not stated; modified itt; R0025439:Supplement Table 3
52	A2 vs A6	md	-1.8 mmHg	-5.7 to 2.0	not stated; modified itt; R0025439:Supplement Table 3
52	A2 vs A6	md	-2.1 mmHg	-6.6 to 2.5	not stated; modified itt; R0025439:Supplement Table 3
52	A3	change	-4.0 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A3	change	-2.8 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A3 vs A1	md	-2.3 mmHg	-6.3 to 1.7	not stated; modified itt; R0025439:Supplement Table 3
52	A3 vs A1	md	-2.6 mmHg	-7.1 to 2.0	not stated; modified itt; R0025439:Supplement Table 3
52	A3 vs A6	md	-1.7 mmHg	-5.6 to 2.2	not stated; modified itt; R0025439:Supplement Table 3
52	A3 vs A6	md	-1.0 mmHg	-5.6 to 3.7	not stated; modified itt; R0025439:Supplement Table 3
52	A4	change	-7.0 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A4	change	-6.3 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A4 vs A1	md	-5.3 mmHg	-9.2 to -1.3	not stated; modified itt; R0025439:Supplement Table 3
52	A4 vs A1	md	-6.0 mmHg	-10.5 to -1.6	not stated; modified itt; R0025439:Supplement Table 3
52	A4 vs A6	md	-4.7 mmHg	-8.6 to -0.9	not stated; modified itt; R0025439:Supplement Table 3
52	A4 vs A6	md	-4.4 mmHg	-9.0 to 0.1	not stated; modified itt; R0025439:Supplement Table 3
52	A5	change	-4.9 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A5	change	-5.4 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A5 vs A1	md	-3.3 mmHg	-7.3 to 0.7	not stated; modified itt; R0025439:Supplement Table 3
52	A5 vs A1	md	-5.2 mmHg	-9.5 to -0.8	not stated; modified itt; R0025439:Supplement Table 3
52	A5 vs A6	md	-2.5 mmHg	-6.4 to 1.4	not stated; modified itt; R0025439:Supplement Table 3
52	A5 vs A6	md	-3.6 mmHg	-8.1 to 0.9	not stated; modified itt; R0025439:Supplement Table 3
52	A6	change	-2.3 mmHg		not stated; modified itt; R0025439:Supplement Table 3
52	A6	change	-1.8 mmHg		not stated; modified itt; R0025439:Supplement Table 3

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

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A1	responders	28	98	not stated; modified itt; R0025439:Figure 2
52	A2	responders	43	94	not stated; modified itt; R0025439:Figure 2
52	A3	responders	51	90	not stated; modified itt; R0025439:Figure 2
52	A4	responders	53	92	not stated; modified itt; R0025439:Figure 2
52	A5	responders	73	92	not stated; modified itt; R0025439:Figure 2
52	A6	responders	44	95	not stated; modified itt; R0025439:Figure 2

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

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A1	responders	10	98	not stated; modified itt; R0025439:Figure 2
52	A2	responders	17	94	not stated; modified itt; R0025439:Figure 2
52	A3	responders	26	90	not stated; modified itt; R0025439:Figure 2
52	A4	responders	27	92	not stated; modified itt; R0025439:Figure 2
52	A5	responders	37	92	not stated; modified itt; R0025439:Figure 2
52	A6	responders	14	95	not stated; modified itt; R0025439:Figure 2

Physical functioning (any instrument) (6 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Detail
52	A1	change	8.7 points	15	not stated; modified itt; R0025439:Supplement Table 7
52	A2	change	7.7 points	13	not stated; modified itt; R0025439:Supplement Table 7
52	A3	change	11 points	16	not stated; modified itt; R0025439:Supplement Table 7
52	A4	change	9.1 points	16	not stated; modified itt; R0025439:Supplement Table 7
52	A5	change	14 points	16	not stated; modified itt; R0025439:Supplement Table 7
52	A6	change	11 points	12	not stated; modified itt; R0025439:Supplement Table 7

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	3 / 98	not stated; randomized; R0025439:Table 2
A2	events	2 / 95	not stated; randomized; R0025439:Table 2
A3	events	7 / 90	not stated; randomized; R0025439:Table 2
A4	events	4 / 93	not stated; randomized; R0025439:Table 2
A5	events	7 / 93	not stated; randomized; R0025439:Table 2
A6	events	2 / 95	not stated; randomized; R0025439:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 98	not stated; randomized; R0025439:Table 2
A2	events	5 / 95	not stated; randomized; R0025439:Table 2
A3	events	6 / 90	not stated; randomized; R0025439:Table 2
A4	events	12 / 93	not stated; randomized; R0025439:Table 2
A5	events	7 / 93	not stated; randomized; R0025439:Table 2
A6	events	3 / 95	not stated; randomized; R0025439:Table 2

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	7 / 98	not stated; randomized; R0025439:Table 2
A2	events	23 / 95	not stated; randomized; R0025439:Table 2
A3	events	29 / 90	not stated; randomized; R0025439:Table 2
A4	events	35 / 93	not stated; randomized; R0025439:Table 2
A5	events	45 / 93	not stated; randomized; R0025439:Table 2
A6	events	7 / 95	not stated; randomized; R0025439:Table 2

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 98	not stated; randomized; R0025439:Table 2
A2	events	5 / 95	not stated; randomized; R0025439:Table 2
A3	events	9 / 90	not stated; randomized; R0025439:Table 2
A4	events	14 / 93	not stated; randomized; R0025439:Table 2
A5	events	12 / 93	not stated; randomized; R0025439:Table 2
A6	events	2 / 95	not stated; randomized; R0025439:Table 2

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	10 / 98	not stated; randomized; R0025439:Table 2
A2	events	8 / 95	not stated; randomized; R0025439:Table 2
A3	events	9 / 90	not stated; randomized; R0025439:Table 2
A4	events	12 / 93	not stated; randomized; R0025439:Table 2
A5	events	14 / 93	not stated; randomized; R0025439:Table 2
A6	events	28 / 95	not stated; randomized; R0025439:Table 2

Constipation (6 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	12 / 98	not stated; randomized; R0025439:Table 2
A2	events	15 / 95	not stated; randomized; R0025439:Table 2
A3	events	11 / 90	not stated; randomized; R0025439:Table 2
A4	events	21 / 93	not stated; randomized; R0025439:Table 2
A5	events	17 / 93	not stated; randomized; R0025439:Table 2
A6	events	7 / 95	not stated; randomized; R0025439:Table 2