parallel randomized trial

NCT01272232

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

Type 2 diabetes (adults)NCT01272232S001792

Design

Randomized: 846
Start year: 2011
Treatment: 56 weeks, follow-up 68 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility: adults with T2D, BMI 27 or more, HbA1c 7.0 to 10.0 percent, diet alone or up to 3 oral drugs

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
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	diet and exercise alone or up to three of metformin, SU, TZD; lifestyle: standard	423	412	324
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	diet and exercise alone or up to three of metformin, SU, TZD; lifestyle: standard	211	204	164
A3	Placebo Placebo	diet and exercise alone or up to three of metformin, SU, TZD; lifestyle: standard	212	211	140

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	Liraglutide 1.8 mg subcutaneous once daily A2	Placebo A3
age	mean (years)	55.0	54.9	54.7
age	sd (years)	10.8	10.7	9.8
asian	n	11	4	4
black	n	44	27	27
bmi	mean (kg/m2)	37.1	37.0	37.4
bmi	sd (kg/m2)	6.5	6.9	7.1
diabetes duration	mean (years)	7.54	7.43	6.71
diabetes duration	sd (years)	5.65	5.16	5.07
female	n	203	103	115
hba1c	mean (percent)	7.9	8.0	7.9
hba1c	sd (percent)	0.8	0.8	0.8
hispanic	n	46	17	24
other race american indian alaska native	n	4	0	0
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	0	0	0
weight	mean (kg)	105.7	105.8	106.5
weight	sd (kg)	21.9	21.0	21.3
white	n	353	177	175

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	-1.3 percent	0.9		412	not stated; full analysis; registry:outcomes
56	A1 vs A2	md	-0.19 percent		-0.34 to -0.04		not stated; full analysis; registry:outcomes
56	A1 vs A3	md	-0.93 percent		-1.08 to -0.78		not stated; full analysis; registry:outcomes
56	A2	change	-1.1 percent	1.0		204	not stated; full analysis; registry:outcomes
56	A2 vs A3	md	-0.74 percent		-0.91 to -0.57		not stated; full analysis; registry:outcomes
56	A3	change	-0.3 percent	0.9		211	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1	responders	69.2		412	not stated; full analysis; registry:outcomes
56	A1 vs A2	or	1.14	0.76 to 1.71		not stated; full analysis; registry:outcomes
56	A1 vs A3	or	8.79	5.74 to 13.4		not stated; full analysis; registry:outcomes
56	A2	responders	66.7		204	not stated; full analysis; registry:outcomes
56	A2 vs A3	or	7.71	4.76 to 12.51		not stated; full analysis; registry:outcomes
56	A3	responders	27.2		211	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	187 / 422	not stated; safety; hypoglycaemia; registry:adverse_events
A2	events	84 / 210	not stated; safety; hypoglycaemia; registry:adverse_events
A3	events	59 / 212	not stated; safety; hypoglycaemia; registry:adverse_events

Percent body weight change (12 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	percent change	-5.9 percent	5.5		412	not stated; full analysis; registry:outcomes
56	A1 vs A2	md	-1.35 percent		-2.23 to -0.48		not stated; full analysis; registry:outcomes
56	A1 vs A3	md	-3.97 percent		-4.84 to -3.11		not stated; full analysis; registry:outcomes
56	A2	percent change	-4.6 percent	5.5		204	not stated; full analysis; registry:outcomes
56	A2 vs A3	md	-2.62 percent		-3.63 to -1.62		not stated; full analysis; registry:outcomes
56	A3	percent change	-2.0 percent	4.3		211	not stated; full analysis; registry:outcomes
68	A1	percent change	-4.7 percent	5.0		324	not stated; full analysis; registry:outcomes
68	A1 vs A2	md	-0.97 percent		-2.02 to 0.09		not stated; full analysis; registry:outcomes
68	A1 vs A3	md	-2.17 percent		-3.32 to -1.02		not stated; full analysis; registry:outcomes
68	A2	percent change	-3.6 percent	5.7		164	not stated; full analysis; registry:outcomes
68	A2 vs A3	md	-1.20 percent		-2.51 to 0.11		not stated; full analysis; registry:outcomes
68	A3	percent change	-2.7 percent	5.8		140	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	49.9		412	not stated; full analysis; registry:outcomes
56	A1 vs A2	or	1.84	1.29 to 2.64		not stated; full analysis; registry:outcomes
56	A1 vs A3	or	6.81	4.34 to 10.68		not stated; full analysis; registry:outcomes
56	A2	responders	35.6		204	not stated; full analysis; registry:outcomes
56	A2 vs A3	or	3.69	2.24 to 6.09		not stated; full analysis; registry:outcomes
56	A3	responders	13.8		211	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	23.4		412	not stated; full analysis; registry:outcomes
56	A1 vs A2	or	1.85	1.16 to 2.95		not stated; full analysis; registry:outcomes
56	A1 vs A3	or	7.10	3.48 to 14.48		not stated; full analysis; registry:outcomes
56	A2	responders	14.4		204	not stated; full analysis; registry:outcomes
56	A2 vs A3	or	3.84	1.75 to 8.41		not stated; full analysis; registry:outcomes
56	A3	responders	4.3		211	not stated; full analysis; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 422	not stated; safety; R0026209:Table 7
	A3	events				0 / 212	not stated; safety; R0026209:Table 7

Three point MACE (5 lines; O21)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			2 /	not stated; safety; R0013170:Table 1
A1 vs A3	hr	0.31	0.05 to 1.88		not stated; safety; R0013170:Table 1
A2	events			3 /	not stated; safety; R0013170:Table 1
A2 vs A3	hr	0.94	0.19 to 4.67		not stated; safety; R0013170:Table 1
A3	events			3 /	not stated; safety; R0013170:Table 1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	37 / 422	not stated; safety; R0026209:Table 7
A2	events	18 / 210	not stated; safety; registry:adverse_events
A3	events	13 / 212	not stated; safety; R0026209:Table 7

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	39 / 423	not stated; randomized; registry:flow
A1	events	39 / 422	not stated; safety; R0026209:Table 7
A2	events	18 / 211	not stated; randomized; registry:flow
A3	events	7 / 212	not stated; safety; R0026209:Table 7
A3	events	7 / 212	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	138 / 422	not stated; safety; registry:adverse_events
A2	events	66 / 210	not stated; safety; registry:adverse_events
A3	events	29 / 212	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	66 / 422	not stated; safety; registry:adverse_events
A2	events	21 / 210	not stated; safety; registry:adverse_events
A3	events	12 / 212	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	108 / 422	not stated; safety; registry:adverse_events
A2	events	37 / 210	not stated; safety; registry:adverse_events
A3	events	27 / 212	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	68 / 422	not stated; safety; registry:adverse_events
A2	events	20 / 210	not stated; safety; registry:adverse_events
A3	events	13 / 212	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 422	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	1 / 422	not stated; safety; bile duct obstruction; registry:adverse_events
A1	events	3 / 422	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 210	not stated; safety; bile duct obstruction; registry:adverse_events
A2	events	0 / 210	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 210	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 212	not stated; safety; bile duct obstruction; registry:adverse_events
A3	events	0 / 212	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 212	not stated; safety; cholecystitis acute; registry:adverse_events

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 422	not stated; safety; thyroid cancer; registry:adverse_events
A2	events	0 / 210	not stated; safety; thyroid cancer; registry:adverse_events
A3	events	1 / 212	not stated; safety; thyroid cancer; registry:adverse_events