parallel randomized trial

STRIVE

EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)

Overweight or obesity without diabetes (adults)NCT03036800S001687

Design

Randomized: 392
Start year: 2017
Treatment: 104 weeks, follow-up 104 weeks
Countries: Ireland, United Kingdom (5 sites)
Sponsor: University of Leicester (industry)
Eligibility: age 18 to 75; BMI 35 or more plus prediabetes, T2D, hypertension or sleep apnea; no insulin or GLP-1 RA

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none, complete cases

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Specialist weight management care alone	Tier 3 specialist weight management service care; lifestyle: intensive	132	93
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg targeted prescribing pathway plus specialist care	Tier 3 specialist weight management service care; lifestyle: intensive	260	201

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Liraglutide 3.0 mg subcutaneous once daily A2
age	mean (years)	51.8	51.1
age	sd (years)	10.8	10.8
asian	n	3	11
asian	percent	2.3	4.2
black	n	11	13
black	percent	8.3	5.0
bmi	mean (kg/m2)	45.5	46.2
bmi	sd (kg/m2)	7.3	7.8
female	n	79	173
female	percent	59.9	66.5
hba1c diabetes:t2d	mean (percent)	7.3	7.4
hba1c diabetes:t2d	sd (percent)	1.1	1.5
hba1c	mean (percent)	6.2	6.4
hba1c	sd (percent)	1.0	1.3
metformin use diabetes:t2d	n	28	59
metformin use diabetes:t2d	percent	68.3	60.2
other race mixed other	n	4	11
other race mixed other	percent	3.0	4.2
other sulfonylurea use diabetes:t2d	n	1	5
other sulfonylurea use diabetes:t2d	percent	2.4	5.1
other tzd use diabetes:t2d	n	1	1
other tzd use diabetes:t2d	percent	2.4	1.0
sbp	mean (mmHg)	138.1	135.8
sbp	sd (mmHg)	17.8	18.3
sglt2i use diabetes:t2d	n	4	6
sglt2i use diabetes:t2d	percent	9.8	6.1
waist	mean (cm)	131.8	132.4
waist	sd (cm)	13.0	15.6
weight	mean (kg)	127.1	129.0
weight	sd (kg)	21.4	25.3
white	n	114	225
white	percent	86.4	86.5

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52	A1	change	0.0 percent	0.9	17	not stated; completers; diabetes:t2d; R0020855:Supplement Table S8
52	A2	change	-1.2 percent	1.7	53	not stated; completers; diabetes:t2d; R0020855:Supplement Table S8
104	A1	change	-0.2 percent	1.3	17	not stated; completers; diabetes:t2d; R0020855:Supplement Table S8
104	A2	change	-1.0 percent	1.8	38	not stated; completers; diabetes:t2d; R0020855:Supplement Table S8

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Events / N	Detail
52	A1	responders	6 / 17	not stated; completers; diabetes:t2d; R0020855:Supplement Table S9
52	A2	responders	44 / 54	not stated; completers; diabetes:t2d; R0020855:Supplement Table S9
104	A1	responders	7 / 17	not stated; completers; diabetes:t2d; R0020855:Supplement Table S9
104	A2	responders	29 / 39	not stated; completers; diabetes:t2d; R0020855:Supplement Table S9

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-3.2 mmHg	17.3		62	not stated; completers; R0020855:Table 3
52	A2	change	-3.9 mmHg	16.7		139	not stated; completers; R0020855:Table 3
52	A2 vs A1	md	-0.72 mmHg		-5.85 to 4.41		not stated; completers; R0020855:Table 3
104	A1	change	-5.6 mmHg	17.8		51	not stated; completers; R0020855:Table 3
104	A2	change	-2.0 mmHg	16.1		94	not stated; completers; R0020855:Table 3
104	A2 vs A1	md	3.00 mmHg		-2.61 to 8.62		not stated; completers; R0020855:Table 3

Percent body weight change (9 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
32	A1	percent change	-4.58 percent	5.74		79	not stated; completers; registry:outcomes
32	A2	percent change	-9.00 percent	5.82		208	not stated; completers; registry:outcomes
32	A2 vs A1	md	-4.70 percent		-6.14 to -3.25		not stated; completers; registry:outcomes
52	A1	percent change	-2.7 percent	6.8		93	not stated; completers; R0020855:Table 2
52	A2 vs A1	md	-5.4 percent		-7.0 to -3.7		not stated; completers; R0020855:Table 2
52	A2	percent change	-8.1 percent	7.2		201	not stated; completers; R0020855:Table 2
104	A1	percent change	-1.2 percent	8.2		61	not stated; completers; R0020855:Table 2
104	A2 vs A1	md	-4.1 percent		-6.4 to -1.8		not stated; completers; R0020855:Table 2
104	A2	percent change	-5.2 percent	7.5		132	not stated; completers; R0020855:Table 2

Weight loss of 5 percent or more (9 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
32	A1	responders			34 / 79	not stated; completers; R0020855:Supplement Table S4
32	A2 vs A1	or	5.2	2.9 to 9.4		not stated; completers; R0020855:Supplement Table S4
32	A2	responders			158 / 208	not stated; completers; R0020855:Supplement Table S4
52	A1	responders			29 / 93	not stated; completers; R0020855:Table 2
52	A2	responders			127 / 201	not stated; completers; R0020855:Table 2
52	A2 vs A1	or	4.2	2.4 to 7.2		not stated; completers; R0020855:Table 2
104	A1	responders			17 / 61	not stated; completers; R0020855:Table 2
104	A2	responders			62 / 132	not stated; completers; R0020855:Table 2
104	A2 vs A1	or	2.4	1.2 to 4.8		not stated; completers; R0020855:Table 2

Weight loss of 10 percent or more (9 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
32	A1	responders			14 / 79	not stated; completers; R0020855:Supplement Table S4
32	A2	responders			110 / 208	not stated; completers; R0020855:Supplement Table S4
32	A2 vs A1	or	6.5	3.3 to 12.9		not stated; completers; R0020855:Supplement Table S4
52	A1	responders			9 / 93	not stated; completers; R0020855:Table 2
52	A2 vs A1	or	8.1	3.8 to 17.2		not stated; completers; R0020855:Table 2
52	A2	responders			90 / 201	not stated; completers; R0020855:Table 2
104	A1	responders			8 / 61	not stated; completers; R0020855:Table 2
104	A2 vs A1	or	2.3	1.0 to 5.5		not stated; completers; R0020855:Table 2
104	A2	responders			32 / 132	not stated; completers; R0020855:Table 2

Weight loss of 15 percent or more (16 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
32	A1	responders			5 / 79	not stated; completers; R0020855:Supplement Table S4
32	A2	responders			32 / 208	not stated; completers; R0020855:Supplement Table S4
32	A2 vs A1	or	3.2	1.2 to 8.9		not stated; completers; R0020855:Supplement Table S4
52	A1	responders			6 / 93	not stated; completers; R0020855:Table 2
52	A1	responders			5 / 51	not stated; per protocol; R0020855:Table 2
52	A1	responders			6 / 132	not stated; randomized; R0020855:Table 2
52	A2	responders			55 / 260	not stated; randomized; R0020855:Table 2
52	A2	responders			51 / 201	not stated; completers; R0020855:Table 2
52	A2	responders			40 / 108	not stated; per protocol; R0020855:Table 2
52	A2 vs A1	or	5.2	2.1 to 12.9		not stated; completers; R0020855:Table 2
52	A2 vs A1	or	6.3	2.4 to 16.5		not stated; completers; R0020855:Table 2
52	A2 vs A1	or	5.9	2.5 to 14.4		not stated; randomized; R0020855:Table 2
52	A2 vs A1	or	5.0	1.8 to 14.0		not stated; per protocol; R0020855:Table 2
104	A1	responders			2 / 61	not stated; completers; R0020855:Table 2
104	A2	responders			15 / 132	not stated; completers; R0020855:Table 2
104	A2 vs A1	or	4.1	0.9 to 18.9		not stated; completers; R0020855:Table 2

Progression to type 2 diabetes (8 lines; O14)

Arm	Statistic	Events / N	Detail
A1	events	3 / 7	not stated; completers; glycemic_status:prediabetes; R0020855:Supplement Table S7
A1	events	0 / 19	not stated; completers; glycemic_status:normoglycemia; R0020855:Supplement Table S7
A1	events	0 / 24	not stated; completers; glycemic_status:normoglycemia; R0020855:Supplement Table S7
A1	events	2 / 9	not stated; completers; glycemic_status:prediabetes; R0020855:Supplement Table S7
A2	events	0 / 52	not stated; completers; glycemic_status:normoglycemia; R0020855:Supplement Table S7
A2	events	2 / 25	not stated; completers; glycemic_status:normoglycemia; R0020855:Supplement Table S7
A2	events	1 / 13	not stated; completers; glycemic_status:prediabetes; R0020855:Supplement Table S7
A2	events	1 / 21	not stated; completers; glycemic_status:prediabetes; R0020855:Supplement Table S7

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 132	not stated; safety; R0020855:Table 4
	A2	events				2 / 260	not stated; safety; R0020855:Table 4

Health related quality of life total score (any instrument) (12 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	12.2 points	13.6		63	not stated; completers; R0020855:Table 3
52	A1	change	-2.7 points	17.7		60	not stated; completers; R0020855:Table 3
52	A2 vs A1	md	5.70 points		0.87 to 10.53		not stated; completers; R0020855:Table 3
52	A2 vs A1	md	5.62 points		-0.85 to 12.10		not stated; completers; R0020855:Table 3
52	A2	change	17.5 points	18.1		139	not stated; completers; R0020855:Table 3
52	A2	change	2.6 points	23.6		132	not stated; completers; R0020855:Table 3
104	A1	change	-0.1 points	20.9		50	not stated; completers; R0020855:Table 3
104	A1	change	-5.7 points	15.6		53	not stated; completers; R0020855:Table 3
104	A2 vs A1	md	1.54 points		-3.46 to 6.54		not stated; completers; R0020855:Table 3
104	A2	change	-1.5 points	27.1		101	not stated; completers; R0020855:Table 3
104	A2	change	-4.3 points	14.1		105	not stated; completers; R0020855:Table 3
104	A2 vs A1	md	-0.17 points		-8.76 to 8.41		not stated; completers; R0020855:Table 3

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	11 / 132	not stated; safety; R0020855:Table 4
A1	events	16 / 132	not stated; safety; registry:adverse_events
A2	events	33 / 260	not stated; safety; R0020855:Table 4
A2	events	43 / 260	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				5 / 260	not stated; safety; R0020855:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 132	not stated; safety; R0020855:Table 4
A1	events	5 / 132	not stated; safety; registry:adverse_events
A2	events	95 / 260	not stated; safety; R0020855:Table 4
A2	events	109 / 260	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 132	not stated; safety; R0020855:Table 4
	A2	events				37 / 260	not stated; safety; R0020855:Table 4

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	1 / 132	not stated; safety; R0020855:Table 4
A1	events	8 / 132	not stated; safety; registry:adverse_events
A2	events	72 / 260	not stated; safety; registry:adverse_events
A2	events	66 / 260	not stated; safety; R0020855:Table 4

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 132	not stated; safety; R0020855:Table 4
	A2	events				84 / 260	not stated; safety; R0020855:Table 4

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 132	not stated; safety; cholecystitis; R0020855:Table 4
A1	events	0 / 132	not stated; safety; cholecystitis; registry:adverse_events
A2	events	1 / 260	not stated; safety; cholecystitis; R0020855:Table 4
A2	events	3 / 260	not stated; safety; cholecystitis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 132	not stated; safety; R0020855:Table 4
	A2	events				2 / 260	not stated; safety; R0020855:Table 4