parallel randomized trial

SUSTAIN 10

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT03191396S000584

Design

Randomized: 577
Start year: 2017
Treatment: 30 weeks, follow-up 35 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility: adults with T2D, HbA1c 7.0 to 11.0 percent on 1 to 3 oral drugs

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	1 to 3 oral glucose lowering drugs; lifestyle: not reported	290	290
A2	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	1 to 3 oral glucose lowering drugs; lifestyle: not reported	287	287

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Liraglutide 1.2 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)	60.1	58.9
age	sd (years)	10.5	10.0
asian	n	5	3
black	n	2	1
diabetes duration	mean (years)			9.3
diabetes duration	sd (years)			5.9
egfr	mean (mL/min/1.73 m2)			92.4
egfr	sd (mL/min/1.73 m2)			17.3
female	n	130	120
hba1c	mean (percent)			8.2
hba1c	sd (percent)			1.0
hispanic	n	6	3
metformin use	n			547
metformin use	percent			94.8
other background metformin and su	percent			35.2
other background metformin only	percent			36.6
other egfr below 60	n			29
other egfr below 60	percent			5.0
other race american indian alaska native	n	0	0
other race multiple	n	3	0
other race native hawaiian pacific islander	n	0	0
sbp	mean (mmHg)			136.4
sbp	sd (mmHg)			14.8
weight	mean (kg)			96.9
weight	sd (kg)			21.3
white	n	264	268

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1 vs A2	md	-0.69 percent		-0.82 to -0.56		not stated; full analysis; registry:outcomes
30	A1	change	-1.7 percent	0.9		290	not stated; full analysis; registry:outcomes
30	A1 vs A2	md	-0.59 percent		-0.81 to -0.36		hypothetical; full analysis; background:metformin_su; R0012216:Figure 1
30	A1	change	-1.76 percent	0.08			hypothetical; full analysis; background:metformin; R0012216:Figure 1
30	A1 vs A2	md	-0.69 percent		-0.91 to -0.47		hypothetical; full analysis; background:metformin; R0012216:Figure 1
30	A1	change	-1.83 percent	0.08			hypothetical; full analysis; background:metformin_su; R0012216:Figure 1
30	A2	change	-1.1 percent	1.0		287	not stated; full analysis; registry:outcomes
30	A2	change	-1.24 percent	0.08			hypothetical; full analysis; background:metformin_su; R0012216:Figure 1
30	A2	change	-1.07 percent	0.08			hypothetical; full analysis; background:metformin; R0012216:Figure 1

Body weight change in kilograms (diabetes) (9 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1 vs A2	md	-3.83 kg		-4.57 to -3.09		not stated; full analysis; registry:outcomes
30	A1	change	-5.8 kg	4.7		290	not stated; full analysis; registry:outcomes
30	A1	change	-5.74 kg	0.45			hypothetical; full analysis; background:metformin_su; R0012216:Figure 1
30	A1 vs A2	md	-3.11 kg		-4.36 to -1.85		hypothetical; full analysis; background:metformin_su; R0012216:Figure 1
30	A1	change	-6.33 kg	0.45			hypothetical; full analysis; background:metformin; R0012216:Figure 1
30	A1 vs A2	md	-4.18 kg		-5.42 to -2.95		hypothetical; full analysis; background:metformin; R0012216:Figure 1
30	A2	change	-2.0 kg	4.1		287	not stated; full analysis; registry:outcomes
30	A2	change	-2.15 kg	0.45			hypothetical; full analysis; background:metformin; R0012216:Figure 1
30	A2	change	-2.63 kg	0.46			hypothetical; full analysis; background:metformin_su; R0012216:Figure 1

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	responders	80.4			290	not stated; full analysis; registry:outcomes
30	A2	responders	45.9			287	not stated; 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				5 / 289	not stated; safety; registry:outcomes
	A2	events				7 / 287	not stated; safety; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-4.3 mmHg	13.4		290	not stated; full analysis; registry:outcomes
30	A2	change	-3.7 mmHg	13.8		287	not stated; full analysis; registry:outcomes

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	percent change	-6.1 percent	4.9		290	not stated; full analysis; registry:outcomes
30	A2	percent change	-2.0 percent	4.2		287	not stated; full analysis; registry:outcomes

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	responders	55.9			290	not stated; full analysis; registry:outcomes
30	A2	responders	17.7			287	not stated; full analysis; registry:outcomes

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	responders	19.1			290	not stated; full analysis; registry:outcomes
30	A2	responders	4.4			287	not stated; full analysis; registry:outcomes

Acute kidney injury (6 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 14	not stated; full analysis; egfr:<60; R0006400:Table 3
A1	events	0 / 289	not stated; safety; registry:adverse_events
A1	events	0 / 276	not stated; full analysis; egfr:>=60; R0006400:Table 3
A2	events	1 / 15	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	0 / 272	not stated; full analysis; egfr:>=60; R0006400:Table 3
A2	events	1 / 287	not stated; safety; registry:adverse_events

All cause mortality (6 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 289	not stated; safety; registry:adverse_events
A1	events	0 / 14	not stated; full analysis; egfr:<60; R0006400:Table 3
A1	events	0 / 276	not stated; full analysis; egfr:>=60; R0006400:Table 3
A2	events	0 / 287	not stated; safety; registry:adverse_events
A2	events	0 / 15	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	0 / 272	not stated; full analysis; egfr:>=60; R0006400:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	2.1 points	6.4		290	not stated; full analysis; registry:outcomes
30	A2	change	1.4 points	5.9		287	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (2 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	1.8 points	5.8		290	not stated; full analysis; registry:outcomes
30	A2	change	1.4 points	6.6		287	not stated; 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
30	A1	change	4.6 points	7.0		290	not stated; full analysis; registry:outcomes
30	A2	change	4.2 points	6.6		287	not stated; full analysis; registry:outcomes

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	18 / 276	not stated; full analysis; egfr:>=60; R0006400:Table 3
A1	events	17 / 289	not stated; safety; registry:adverse_events
A1	events	0 / 14	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	22 / 287	not stated; safety; registry:adverse_events
A2	events	1 / 15	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	22 / 272	not stated; full analysis; egfr:>=60; R0006400:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	29 / 276	not stated; full analysis; egfr:>=60; R0006400:Table 3
A1	events	4 / 14	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	1 / 15	not stated; full analysis; egfr:<60; R0006400:Table 3
A2	events	19 / 272	not stated; full analysis; egfr:>=60; R0006400:Table 3

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	62 / 289	not stated; safety; registry:adverse_events
A1	events	1 / 289	not stated; safety; registry:adverse_events
A2	events	45 / 287	not stated; safety; registry:adverse_events
A2	events	0 / 287	not stated; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 289	not stated; safety; registry:adverse_events
A1	events	29 / 289	not stated; safety; registry:adverse_events
A2	events	1 / 287	not stated; safety; registry:adverse_events
A2	events	23 / 287	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	45 / 289	not stated; safety; registry:adverse_events
A1	events	0 / 289	not stated; safety; registry:adverse_events
A2	events	35 / 287	not stated; safety; registry:adverse_events
A2	events	1 / 287	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 289	not stated; safety; registry:adverse_events
	A2	events				10 / 287	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 289	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 289	not stated; safety; cholecystitis; registry:adverse_events
A1	events	0 / 289	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 287	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 287	not stated; safety; cholecystitis; registry:adverse_events
A2	events	1 / 287	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 289	not stated; safety; registry:adverse_events
	A2	events				1 / 287	not stated; safety; registry:adverse_events

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 289	not stated; safety; registry:adverse_events
	A2	events				0 / 287	not stated; safety; registry:adverse_events

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 289	not stated; safety; medullary thyroid cancer; registry:adverse_events
	A2	events				0 / 287	not stated; safety; medullary thyroid cancer; registry:adverse_events