parallel randomized trial

SUSTAIN™1

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Design

Randomized: 388
Start year: 2014
Treatment: 30 weeks, follow-up 35 weeks
Countries: multinational
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or older (20 in Japan); HbA1c 7.0 to 10.0 percent; drug naive on diet and exercise; eGFR 30 or more

Arm	Treatment	Background	Randomized	Analyzed
A1	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide 0.5 mg	diet and exercise only; lifestyle: not reported	129	128
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	diet and exercise only; lifestyle: not reported	130	130
A3	Placebo Placebo	diet and exercise only; lifestyle: not reported	129	129

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

Characteristic	Statistic	Semaglutide 0.5 mg subcutaneous once weekly A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Placebo A3	Whole trial ALL
age	mean (years)	54.6	52.7	53.9	53.7
age	sd (years)	11.1	11.9	11.0	11.3
asian	n				83
asian	percent				21.4
black	n				31
black	percent				8.0
bmi	mean (kg/m2)	32.5	33.9		32.9
bmi	sd (kg/m2)	7.6	8.4		7.7
diabetes duration	mean (years)	4.8	3.6		4.2
diabetes duration	sd (years)	6.1	4.9		5.5
egfr	mean (mL/min/1.73 m2)				95.6
egfr	sd (mL/min/1.73 m2)				27.6
female	n	68	50	59	177
female	percent				45.7
hba1c	mean (percent)	8.09	8.12	7.95	8.05
hba1c	sd (percent)	0.89	0.81	0.85	0.85
other retinopathy history	n				15
other retinopathy history	percent				3.9
sbp	mean (mmHg)	127.87	128.89	129.57	128.78
sbp	sd (mmHg)	13.15	12.92	13.50	13.18
weight	mean (kg)	89.81	96.87	89.05	91.93
weight	sd (kg)	22.96	25.59	22.16	23.83
white	n				249
white	percent				64.3

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	-1.47 percent	1.02		128	not stated; full analysis; registry:outcomes
30	A1 vs A3	md	-1.43 percent		-1.71 to -1.15		not stated; full analysis; registry:outcomes
30	A2	change	-1.56 percent	1.26		130	not stated; full analysis; registry:outcomes
30	A2 vs A3	md	-1.53 percent		-1.81 to -1.25		not stated; full analysis; registry:outcomes
30	A3	change	-0.00 percent	0.90		129	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
30	A1	change	-3.68 kg	4.03	128	not stated; full analysis; registry:outcomes
30	A2	change	-4.67 kg	5.19	130	not stated; full analysis; registry:outcomes
30	A3	change	-0.89 kg	3.46	129	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
30	A1	responders	74.2	128	not stated; full analysis; registry:outcomes
30	A2	responders	72.3	130	not stated; full analysis; registry:outcomes
30	A3	responders	24.8	129	not stated; full analysis; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 128	while on treatment; safety; R0021710:Table 2
A2	events	0 / 130	while on treatment; safety; R0021710:Table 2
A3	events	0 / 129	while on treatment; safety; R0021710:Table 2

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
30	A1	change	-2.29 mmHg	12.58	128	not stated; full analysis; registry:outcomes
30	A2	change	-2.74 mmHg	11.58	130	not stated; full analysis; registry:outcomes
30	A3	change	-2.01 mmHg	11.23	129	not stated; full analysis; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	7 / 128	while on treatment; safety; R0021710:Table 2
A2	events	7 / 130	while on treatment; safety; R0021710:Table 2
A3	events	5 / 129	while on treatment; safety; R0021710:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	8 / 128	while on treatment; safety; R0021710:Table 2
A2	events	7 / 130	while on treatment; safety; R0021710:Table 2
A3	events	3 / 129	while on treatment; safety; R0021710:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	26 / 128	not stated; safety; registry:adverse_events
A2	events	31 / 130	not stated; safety; registry:adverse_events
A3	events	10 / 129	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	5 / 128	not stated; safety; registry:adverse_events
A2	events	9 / 130	not stated; safety; registry:adverse_events
A3	events	2 / 129	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	16 / 128	not stated; safety; registry:adverse_events
A2	events	14 / 130	not stated; safety; registry:adverse_events
A3	events	3 / 129	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	8 / 128	not stated; safety; registry:adverse_events
A2	events	5 / 130	not stated; safety; registry:adverse_events
A3	events	1 / 129	not stated; safety; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	5 / 128	while on treatment; safety; R0021710:Table 2
A2	events	4 / 130	while on treatment; safety; R0021710:Table 2
A3	events	1 / 129	while on treatment; safety; R0021710:Table 2

Gallbladder and biliary disease (3 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 128	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 130	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 129	not stated; safety; cholelithiasis; registry:adverse_events