parallel randomized trial

SUSTAIN 7

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT02648204S000372

Design

Randomized: 1,201
Start year: 2016
Treatment: 40 weeks, follow-up 45 weeks
Countries
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 or older; HbA1c 7.0 to 10.5 percent; eGFR 60 or higher; metformin background

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: not_reported

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide 0.5 mg	metformin; lifestyle: not reported	301	301
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	metformin; lifestyle: not reported	300	300
A3	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	metformin; lifestyle: not reported	300	299
A4	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	metformin; lifestyle: not reported	300	299

Baseline characteristics

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	Dulaglutide 0.75 mg subcutaneous once weekly A3	Dulaglutide 1.5 mg subcutaneous once weekly A4	Whole trial ALL
age	mean (years)	56	55	55	56	56
age	sd (years)	10.9	10.6	10.4	10.6	10.6
asian	n	50	38	48	55	191
black	n	17	18	17	18	70
bmi	mean (kg/m2)					33.5
bmi	sd (kg/m2)					6.8
diabetes duration	mean (years)					7.4
diabetes duration	sd (years)					5.7
egfr	mean (mL/min/1.73 m2)					96
female	n	169	162	160	171	537
female	percent					44.8
hba1c	mean (percent)	8.3	8.2	8.2	8.2	8.2
hba1c	sd (percent)	0.96	0.92	0.91	0.89	0.92
hispanic	n	29	35	31	43	138
weight	mean (kg)	96.4	95.5	95.6	93.4	95.2
weight	sd (kg)	24.38	20.90	23.01	21.79	22.56
white	n	233	243	232	220	928

Analyses this trial contributes to

Results

100 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
40	A1	change	-1.51 percent	0.06		301	not stated; full analysis; registry:outcomes
40	A1 vs A3	md	-0.40 percent		-0.55 to -0.25		not stated; full analysis; registry:outcomes
40	A2	change	-1.78 percent	0.06		300	not stated; full analysis; registry:outcomes
40	A2 vs A4	md	-0.41 percent		-0.57 to -0.25		not stated; full analysis; registry:outcomes
40	A3	change	-1.11 percent	0.05		299	not stated; full analysis; registry:outcomes
40	A4	change	-1.37 percent	0.06		299	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
40	A1	change	-4.56 kg	0.28		301	not stated; full analysis; registry:outcomes
40	A1 vs A3	md	-2.26 kg		-3.02 to -1.51		not stated; full analysis; registry:outcomes
40	A2	change	-6.53 kg	0.28		300	not stated; full analysis; registry:outcomes
40	A2 vs A4	md	-3.55 kg		-4.32 to -2.78		not stated; full analysis; registry:outcomes
40	A3	change	-2.30 kg	0.27		299	not stated; full analysis; registry:outcomes
40	A4	change	-2.98 kg	0.27		298	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
40	A1	responders	68.4	301	not stated; full analysis; registry:outcomes
40	A2	responders	78.7	300	not stated; full analysis; registry:outcomes
40	A3	responders	52.2	299	not stated; full analysis; registry:outcomes
40	A4	responders	66.6	299	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	0.7	301	not stated; safety; registry:outcomes
A2	events	1.7	300	not stated; safety; registry:outcomes
A3	events	1.0	299	not stated; safety; registry:outcomes
A4	events	1.7	299	not stated; safety; registry:outcomes

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
40	A1	change	-2.44 mmHg	0.76	301	not stated; full analysis; registry:outcomes
40	A2	change	-4.88 mmHg	0.77	300	not stated; full analysis; registry:outcomes
40	A3	change	-2.16 mmHg	0.75	299	not stated; full analysis; registry:outcomes
40	A4	change	-2.86 mmHg	0.75	299	not stated; full analysis; registry:outcomes

Weight loss of 5 percent or more (4 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
40	A1	responders	43.9	301	not stated; full analysis; registry:outcomes
40	A2	responders	63.0	300	not stated; full analysis; registry:outcomes
40	A3	responders	22.7	299	not stated; full analysis; registry:outcomes
40	A4	responders	30.2	298	not stated; full analysis; registry:outcomes

Weight loss of 10 percent or more (4 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
40	A1	responders	14.3	301	not stated; full analysis; registry:outcomes
40	A2	responders	26.7	300	not stated; full analysis; registry:outcomes
40	A3	responders	3.3	299	not stated; full analysis; registry:outcomes
40	A4	responders	7.7	298	not stated; full analysis; registry:outcomes

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 301	not stated; safety; registry:adverse_events
A2	events	1 / 300	not stated; safety; registry:adverse_events
A3	events	2 / 299	not stated; safety; registry:adverse_events
A4	events	2 / 299	not stated; safety; registry:adverse_events

SF-36 physical component summary change (4 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
40	A1	change	1.21 points	0.40	301	not stated; full analysis; registry:outcomes
40	A2	change	2.04 points	0.40	300	not stated; full analysis; registry:outcomes
40	A3	change	1.93 points	0.39	299	not stated; full analysis; registry:outcomes
40	A4	change	1.29 points	0.39	299	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (4 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
40	A1	change	1.25 points	0.44	301	not stated; full analysis; registry:outcomes
40	A2	change	2.00 points	0.44	300	not stated; full analysis; registry:outcomes
40	A3	change	2.17 points	0.43	299	not stated; full analysis; registry:outcomes
40	A4	change	1.05 points	0.43	299	not stated; full analysis; registry:outcomes

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	17 / 301	not stated; safety; registry:adverse_events
A2	events	23 / 300	not stated; safety; registry:adverse_events
A3	events	24 / 299	not stated; safety; registry:adverse_events
A4	events	22 / 299	not stated; safety; registry:adverse_events

Nausea (8 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	67 / 301	not stated; safety; registry:adverse_events
A1	events	1 / 301	not stated; safety; registry:adverse_events
A2	events	63 / 300	not stated; safety; registry:adverse_events
A2	events	0 / 300	not stated; safety; registry:adverse_events
A3	events	0 / 299	not stated; safety; registry:adverse_events
A3	events	39 / 299	not stated; safety; registry:adverse_events
A4	events	60 / 299	not stated; safety; registry:adverse_events
A4	events	0 / 299	not stated; safety; registry:adverse_events

Vomiting (8 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	30 / 301	not stated; safety; registry:adverse_events
A1	events	1 / 301	not stated; safety; registry:adverse_events
A2	events	31 / 300	not stated; safety; registry:adverse_events
A2	events	0 / 300	not stated; safety; registry:adverse_events
A3	events	12 / 299	not stated; safety; registry:adverse_events
A3	events	0 / 299	not stated; safety; registry:adverse_events
A4	events	29 / 299	not stated; safety; registry:adverse_events
A4	events	0 / 299	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	43 / 301	not stated; safety; registry:adverse_events
A2	events	41 / 300	not stated; safety; registry:adverse_events
A3	events	23 / 299	not stated; safety; registry:adverse_events
A4	events	53 / 299	not stated; safety; registry:adverse_events

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	16 / 301	not stated; safety; registry:adverse_events
A2	events	14 / 300	not stated; safety; registry:adverse_events
A3	events	10 / 299	not stated; safety; registry:adverse_events
A4	events	15 / 299	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (16 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 301	not stated; safety; Cholecystitis acute; registry:adverse_events
A1	events	0 / 301	not stated; safety; Gallbladder pain; registry:adverse_events
A1	events	0 / 301	not stated; safety; Cholecystitis; registry:adverse_events
A1	events	0 / 301	not stated; safety; Cholelithiasis; registry:adverse_events
A2	events	0 / 300	not stated; safety; Cholelithiasis; registry:adverse_events
A2	events	0 / 300	not stated; safety; Cholecystitis; registry:adverse_events
A2	events	0 / 300	not stated; safety; Gallbladder pain; registry:adverse_events
A2	events	1 / 300	not stated; safety; Cholecystitis acute; registry:adverse_events
A3	events	0 / 299	not stated; safety; Cholecystitis acute; registry:adverse_events
A3	events	0 / 299	not stated; safety; Cholelithiasis; registry:adverse_events
A3	events	0 / 299	not stated; safety; Gallbladder pain; registry:adverse_events
A3	events	0 / 299	not stated; safety; Cholecystitis; registry:adverse_events
A4	events	1 / 299	not stated; safety; Gallbladder pain; registry:adverse_events
A4	events	2 / 299	not stated; safety; Cholecystitis acute; registry:adverse_events
A4	events	1 / 299	not stated; safety; Cholecystitis; registry:adverse_events
A4	events	1 / 299	not stated; safety; Cholelithiasis; registry:adverse_events

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 301	not stated; safety; pancreatitis acute; registry:adverse_events
A2	events	1 / 300	not stated; safety; pancreatitis acute; registry:adverse_events
A3	events	0 / 299	not stated; safety; pancreatitis acute; registry:adverse_events
A4	events	0 / 299	not stated; safety; pancreatitis acute; registry:adverse_events

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 301	not stated; safety; suicide attempt; registry:adverse_events
A2	events	0 / 300	not stated; safety; suicide attempt; registry:adverse_events
A3	events	1 / 299	not stated; safety; suicide attempt; registry:adverse_events
A4	events	0 / 299	not stated; safety; suicide attempt; registry:adverse_events

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 301	not stated; safety; pancreatic carcinoma stage IV; registry:adverse_events
A2	events	1 / 300	not stated; safety; pancreatic carcinoma stage IV; registry:adverse_events
A3	events	0 / 299	not stated; safety; pancreatic carcinoma stage IV; registry:adverse_events
A4	events	0 / 299	not stated; safety; pancreatic carcinoma stage IV; registry:adverse_events