parallel randomized trial

NCT00422058

Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period

Overweight or obesity without diabetes (adults)NCT00422058S001402

Design

Randomized: 564
Start year: 2007
Treatment: 52 weeks, follow-up 104 weeks
Countries: multinational (19 sites)
Sponsor: Novo Nordisk A/S (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: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: standard	98	98
A2	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	lifestyle: standard	95	94
A3	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle: standard	90	90
A4	Liraglutide 2.4 mg injection once daily Liraglutide 2.4 mg	lifestyle: standard	93	92
A5	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	lifestyle: standard	93	92
A6	Orlistat Orlistat 120 mg three times daily	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
black	n	1	0	2	1	1	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	n	74	73	68	71	70	73
female	percent	75	77	76	76	75	77
hba1c	mean (percent)	5.60	5.58	5.60	5.54	5.57	5.55
hba1c	sd (percent)	0.38	0.33	0.40	0.33	0.40	0.32
other race american indian alaska native	n	0	0	0	0	0	1
other race other	n	0	1	0	1	0	0
sbp	mean (mmHg)	123.6	127.0	123.4	126.2	124.3	122.7
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
white	n	97	94	88	91	92	93

Analyses this trial contributes to

Results

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

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
20	A1	change	-3.2 mmHg	13.3	94	not stated; modified itt; registry:outcomes
20	A2	change	-6.1 mmHg	11.1	88	not stated; modified itt; registry:outcomes
20	A3	change	-4.8 mmHg	12.7	85	not stated; modified itt; registry:outcomes
20	A4	change	-9.1 mmHg	12.3	89	not stated; modified itt; registry:outcomes
20	A5	change	-6.4 mmHg	10.0	89	not stated; modified itt; registry:outcomes
20	A6	change	-4.3 mmHg	10.9	90	not stated; modified itt; registry:outcomes

Three point MACE (1 lines; O21)

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

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 98	not stated; randomized; registry:flow
A2	events	4 / 95	not stated; randomized; registry:flow
A3	events	5 / 90	not stated; randomized; registry:flow
A4	events	9 / 93	not stated; randomized; registry:flow
A5	events	5 / 93	not stated; randomized; registry:flow
A6	events	3 / 95	not stated; randomized; registry:flow

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	7 / 98	not stated; safety; R0026705:Table 2
A2	events	23 / 95	not stated; safety; R0026705:Table 2
A3	events	29 / 90	not stated; safety; R0026705:Table 2
A4	events	35 / 93	not stated; safety; R0026705:Table 2
A5	events	45 / 93	not stated; safety; R0026705:Table 2
A6	events	7 / 95	not stated; safety; R0026705:Table 2

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 98	not stated; safety; R0026705:Table 2
A2	events	5 / 95	not stated; safety; R0026705:Table 2
A3	events	9 / 90	not stated; safety; R0026705:Table 2
A4	events	14 / 93	not stated; safety; R0026705:Table 2
A5	events	12 / 93	not stated; safety; R0026705:Table 2
A6	events	2 / 95	not stated; safety; R0026705:Table 2

Discontinuation due to gastrointestinal adverse events (12 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 98	not stated; safety; nausea; R0026705:Table 2
A1	events	0 / 98	not stated; safety; vomiting; R0026705:Table 2
A2	events	2 / 95	not stated; safety; nausea; R0026705:Table 2
A2	events	0 / 95	not stated; safety; vomiting; R0026705:Table 2
A3	events	2 / 90	not stated; safety; nausea; R0026705:Table 2
A3	events	0 / 90	not stated; safety; vomiting; R0026705:Table 2
A4	events	3 / 93	not stated; safety; nausea; R0026705:Table 2
A4	events	2 / 93	not stated; safety; vomiting; R0026705:Table 2
A5	events	2 / 93	not stated; safety; nausea; R0026705:Table 2
A5	events	3 / 93	not stated; safety; vomiting; R0026705:Table 2
A6	events	0 / 95	not stated; safety; nausea; R0026705:Table 2
A6	events	0 / 95	not stated; safety; vomiting; R0026705:Table 2