parallel randomized trial

SCALE™ Insulin

Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin

Type 2 diabetes (adults)NCT02963922S000159

Design

Randomized: 396
Start year: 2017
Treatment: 56 weeks, follow-up 60 weeks
Countries: multinational (53 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or older; BMI 27 or higher; HbA1c 6.0 to 10 percent; basal insulin plus up to 2 oral drugs

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: jump to reference multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg	basal insulin titrated to fasting target plus up to 2 OADs; lifestyle: intensive	198	198
A2	Placebo Placebo	basal insulin titrated to fasting target plus up to 2 OADs; lifestyle: intensive	198	198

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)	55.9	57.6
age	sd (years)	11.3	10.4
asian	n	3	5
asian	percent	1.5	2.5
black	n	17	11
black	percent	8.6	5.6
bmi	mean (kg/m2)	35.9	35.3
bmi	sd (kg/m2)	6.5	5.8
diabetes duration	mean (years)	11.4	12.8
diabetes duration	sd (years)	6.8	6.9
female	n	108	99
hba1c	mean (percent)	7.9	8
hba1c	sd (percent)	1.1	1.0
hispanic	n	43	29
metformin use	n	175	176
metformin use	percent	88.4	88.9
other male	n	90	99
other male	percent	45.5	50.0
other not hispanic	n	155	169
other not hispanic	percent	78.3	85.4
other race american indian alaska native	n	2	0
other race native hawaiian pacific islander	n	2	0
other race other	n	0	2
other sulfonylurea use	n	68	71
other sulfonylurea use	percent	34.3	35.9
sbp	mean (mmHg)	129.0	132.0
sbp	sd (mmHg)	14.0	16.0
sglt2i use	n	44	44
sglt2i use	percent	22.2	22.2
waist	mean (cm)	114.8	114.2
waist	sd (cm)	13.7	13.2
weight	mean (kg)	100.6	98.9
weight	sd (kg)	20.8	19.9
white	n	174	180
white	percent	87.9	90.9

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1 vs A2	md	-0.5 percent		-0.8 to -0.3		treatment policy; full analysis; R0024063:Table 2
56	A1	change	-1.2 percent	1.1		198	while on treatment; full analysis; registry:outcomes
56	A1	change	-1.1 percent			198	treatment policy; full analysis; R0024063:Table 2
56	A1	change	-1.1 percent	1.2		198	treatment policy; full analysis; registry:outcomes
56	A2	change	-0.6 percent			198	treatment policy; full analysis; R0024063:Table 2
56	A2	change	-0.5 percent	1.2		198	treatment policy; full analysis; registry:outcomes
56	A2	change	-0.7 percent	1.0		198	while on treatment; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				2 / 197	while on treatment; safety; R0024063:Table 3

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	-6 mmHg	14		198	not stated; full analysis; registry:outcomes
56	A1	change	-5.6 mmHg			198	treatment policy; full analysis; R0024063:Table 2
56	A1 vs A2	md	-4.0 mmHg		-6.4 to -1.5		treatment policy; full analysis; R0024063:Table 2
56	A2	change	-2 mmHg	15		198	not stated; full analysis; registry:outcomes
56	A2	change	-1.6 mmHg			198	treatment policy; full analysis; R0024063:Table 2

Percent body weight change (10 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1 vs A2	md	-4.3 percent		-5.5 to -3.2		treatment policy; full analysis; R0024063:Table 2
56	A1	percent change	-6.4 percent			198	hypothetical; full analysis; R0024063:Results
56	A1 vs A2	md	-5.1 percent		-6.3 to -3.9		hypothetical; full analysis; R0024063:Results
56	A1	percent change	-5.8 percent			198	treatment policy; full analysis; R0024063:Table 2
56	A1	percent change	-6.0 percent	6.0		198	treatment policy; full analysis; registry:outcomes
56	A1	percent change	-6.5 percent	5.8		198	while on treatment; full analysis; registry:outcomes
56	A2	percent change	-1.5 percent			198	treatment policy; full analysis; R0024063:Table 2
56	A2	percent change	-1.5 percent	5.4		198	treatment policy; full analysis; registry:outcomes
56	A2	percent change	-1.7 percent	5.2		198	while on treatment; full analysis; registry:outcomes
56	A2	percent change	-1.3 percent			198	hypothetical; full analysis; R0024063:Results

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1	responders	51.8		198	treatment policy; full analysis; R0024063:Table 2
56	A1 vs A2	or	4.73	3.04 to 7.36		hypothetical; full analysis; registry:outcomes
56	A1 vs A2	or	3.41	2.19 to 5.31		treatment policy; full analysis; R0024063:Results
56	A1	responders	56.92		198	while on treatment; full analysis; registry:outcomes
56	A2	responders	24.0		198	treatment policy; full analysis; R0024063:Table 2
56	A2	responders	21.83		198	while on treatment; full analysis; registry:outcomes

Weight loss of 10 percent or more (5 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
56	A1 vs A2	or	4.21	2.2 to 8.2		treatment policy; full analysis; R0024063:Results
56	A1	responders	22.8		198	treatment policy; full analysis; R0024063:Table 2
56	A1	responders	22.56		198	while on treatment; full analysis; registry:outcomes
56	A2	responders	5.58		198	while on treatment; full analysis; registry:outcomes
56	A2	responders	6.6		198	treatment policy; full analysis; R0024063:Table 2

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 195	not stated; safety; registry:adverse_events
A1	events	0 / 195	while on treatment; safety; R0024063:Table 3
A2	events	0 / 197	while on treatment; safety; R0024063:Table 3
A2	events	0 / 197	not stated; safety; registry:adverse_events

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	2.7 points	7.5		198	not stated; full analysis; registry:outcomes
56	A2	change	2.2 points	7.2		198	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (14 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	2.7 points			198	treatment policy; full analysis; R0024063:Table 2
56	A1	change	8.2 points	20.9		198	while on treatment; full analysis; registry:outcomes
56	A1	change	2.9 points	7.8		198	while on treatment; full analysis; registry:outcomes
56	A1	change	2.5 points	7.9		198	treatment policy; full analysis; registry:outcomes
56	A1 vs A2	md	2.5 points		-1.5 to 6.4		treatment policy; full analysis; R0024063:Table 2
56	A1 vs A2	md	0.4 points		-1.0 to 1.8		treatment policy; full analysis; R0024063:Table 2
56	A1	change	8.2 points			198	treatment policy; full analysis; R0024063:Table 2
56	A1	change	7.3 points	22.5		198	treatment policy; full analysis; registry:outcomes
56	A2	change	2.3 points			198	treatment policy; full analysis; R0024063:Table 2
56	A2	change	5.7 points			198	treatment policy; full analysis; R0024063:Table 2
56	A2	change	6.8 points	21.5		198	treatment policy; full analysis; registry:outcomes
56	A2	change	2.6 points	7.3		198	treatment policy; full analysis; registry:outcomes
56	A2	change	6.5 points	21.8		198	while on treatment; full analysis; registry:outcomes
56	A2	change	2.5 points	7.1		198	while on treatment; full analysis; registry:outcomes

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
56	A1	change	5.7 points	17.6		198	not stated; full analysis; registry:outcomes
56	A2	change	4.8 points	16.6		198	not stated; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				19 / 197	while on treatment; safety; R0024063:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	15 / 195	while on treatment; safety; R0024063:Table 3
A1	events	15 / 198	not stated; randomized; registry:flow
A2	events	6 / 197	while on treatment; safety; R0024063:Table 3
A2	events	6 / 198	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				58 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				23 / 197	while on treatment; safety; R0024063:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				32 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				12 / 197	while on treatment; safety; R0024063:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				45 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				30 / 197	while on treatment; safety; R0024063:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				28 / 195	while on treatment; safety; R0024063:Table 3
	A2	events				17 / 197	while on treatment; safety; R0024063:Table 3

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 195	while on treatment; safety; gallbladder disorder; R0024063:Results
A1	events	2 / 195	while on treatment; safety; cholelithiasis; R0024063:Results
A2	events	1 / 197	while on treatment; safety; gallbladder disorder; R0024063:Results
A2	events	0 / 197	while on treatment; safety; cholelithiasis; R0024063:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 195	while on treatment; safety; R0024063:Results
	A2	events				1 / 197	while on treatment; safety; R0024063:Results

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 195	not stated; safety; adenocarcinoma pancreas; registry:adverse_events
	A2	events				0 / 197	not stated; safety; adenocarcinoma pancreas; registry:adverse_events