parallel randomized trial

SURPASS-SWITCH

A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

Type 2 diabetes (adults)NCT05564039S001940

Design

Randomized: 282
Start year: 2022
Treatment: 40 weeks, follow-up 44 weeks
Countries: Belgium, Germany, Mexico, Romania, United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 or older; HbA1c 7.0 to 9.5 percent; BMI 25 or more; stable dulaglutide 0.75 or 1.5 mg

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg or MTD	0 to 3 oral agents (metformin, sulfonylurea, SGLT2 inhibitor); lifestyle: standard	139	139
A2	Dulaglutide 4.5 mg subcutaneous once weekly Dulaglutide 4.5 mg or MTD	0 to 3 oral agents (metformin, sulfonylurea, SGLT2 inhibitor); lifestyle: standard	143	143

Baseline characteristics

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

Characteristic	Statistic	Tirzepatide 15 mg subcutaneous once weekly A1	Dulaglutide 4.5 mg subcutaneous once weekly A2	Whole trial ALL
age: 65 or older	n	35	37
age: 65 or older	percent	25.2	25.9
age: less than 65	n	104	106
age: less than 65	percent	74.8	74.1
age	mean (years)	57.9	57.3
age	sd (years)	9.8	10.0
asian	n	3	1
black	n	4	2
bmi: 27 or more	n	127	128
bmi: 27 or more	percent	91.4	89.5
bmi: 30 to less than 35	n	45	51
bmi: 30 to less than 35	percent	32.4	35.7
bmi: 35 or more	n	61	51
bmi: 35 or more	percent	43.9	35.7
bmi: less than 27	n	12	15
bmi: less than 27	percent	8.6	10.5
bmi: less than 30	n	33	41
bmi: less than 30	percent	23.7	28.7
bmi	mean (kg/m2)			34.3
bmi	sd (kg/m2)			6.3
diabetes duration: 5 or less	n	30	31
diabetes duration: 5 or less	percent	21.6	21.7
diabetes duration: more than 10	n	71	72
diabetes duration: more than 10	percent	51.1	50.3
diabetes duration: more than 5 to 10	n	38	40
diabetes duration: more than 5 to 10	percent	27.3	28.0
diabetes duration	mean (years)			11.2
diabetes duration	sd (years)			7.0
female	n	64	72
female	percent	46.0	50.3
hba1c: 8.5 or less	n	113	121
hba1c: 8.5 or less	percent	81.3	84.6
hba1c: more than 8.5	n	26	22
hba1c: more than 8.5	percent	18.7	15.4
hba1c	mean (percent)	7.82	7.82
hba1c	sd (percent)	0.69	0.73
hispanic	n	61	62
hispanic	percent	43.9	43.4
other race american indian alaska native	n	23	19
other race multiple	n	0	1
other race native hawaiian pacific islander	n	0	0
white	n	109	120

Analyses this trial contributes to

Results

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

HbA1c change (12 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
40	A1	change	-1.59 percent	0.073		114	hypothetical; modified itt; registry:outcomes
40	A1	change	-2.3 percent	0.2		20	hypothetical; modified itt; hba1c:more_than_8.5; R0008264:Results
40	A1 vs A2	md	-1.2 percent		-1.8 to -0.6		hypothetical; modified itt; hba1c:more_than_8.5; R0008264:Results
40	A1 vs A2	md	-0.77 percent		-0.98 to -0.56		treatment policy; modified itt; R0008264:Results
40	A1	change	-1.44 percent	0.07			treatment policy; modified itt; R0008264:Results
40	A1 vs A2	md	-0.90 percent		-1.10 to -0.69		hypothetical; modified itt; registry:outcomes
40	A1	change	-2.0 percent	0.3			hypothetical; modified itt; bmi:less_than_27; R0008264:Results
40	A1 vs A2	md	-1.7 percent		-2.5 to -0.9		hypothetical; modified itt; bmi:less_than_27; R0008264:Results
40	A2	change	-1.1 percent	0.2		15	hypothetical; modified itt; hba1c:more_than_8.5; R0008264:Results
40	A2	change	-0.67 percent	0.08			treatment policy; modified itt; R0008264:Results
40	A2	change	-0.3 percent	0.3			hypothetical; modified itt; bmi:less_than_27; R0008264:Results
40	A2	change	-0.69 percent	0.074		105	hypothetical; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
40	A1 vs A2	md	-9.6 kg		-13.8 to -5.4		hypothetical; modified itt; bmi:less_than_27; R0008264:Results
40	A1 vs A2	md	-8.6 kg		-10.3 to -7.0		hypothetical; modified itt; ethnicity:not_hispanic_or_latino; R0008264:Results
40	A1	change	-11.0 kg	0.48		123	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	md	-7.4 kg		-8.7 to -6.0		hypothetical; modified itt; registry:outcomes
40	A1	change	-10.5 kg	0.5			treatment policy; modified itt; R0008264:Results
40	A1 vs A2	md	-6.9 kg		-8.3 to -5.5		treatment policy; modified itt; R0008264:Results
40	A1 vs A2	md	-5.9 kg		-8.1 to -3.7		hypothetical; modified itt; ethnicity:hispanic_or_latino; R0008264:Results
40	A2	change	-3.6 kg	0.49		111	hypothetical; modified itt; registry:outcomes
40	A2	change	-3.6 kg	0.5			treatment policy; modified itt; R0008264:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
40	A1	responders	84.21		114	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	or	7.13	3.82 to 13.32		hypothetical; modified itt; registry:outcomes
40	A2	responders	52.38		105	hypothetical; modified itt; 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	5.8			139	not stated; modified itt; R0008264:Results
	A2	events	2.8			143	not stated; modified itt; R0008264:Results

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
40	A1	responders	84.33		134	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	or	9.31	5.11 to 16.98		hypothetical; modified itt; registry:outcomes
40	A2	responders	37.40		131	hypothetical; modified itt; registry:outcomes

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
40	A1	responders	58.21		134	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	or	19.35	9.07 to 41.30		hypothetical; modified itt; registry:outcomes
40	A2	responders	6.87		131	hypothetical; modified itt; registry:outcomes

Weight loss of 15 percent or more (3 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
40	A1	responders	27.61		134	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	or	35.83	7.18 to 178.89		hypothetical; modified itt; registry:outcomes
40	A2	responders	0.76		131	hypothetical; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 139	not stated; safety; registry:adverse_events
	A2	events				1 / 143	not stated; safety; registry:adverse_events

Physical functioning (any instrument) (3 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
40	A1	change	11.8 points	1.77		121	hypothetical; modified itt; registry:outcomes
40	A1 vs A2	md	4.1 points		-1.0 to 9.2		hypothetical; modified itt; registry:outcomes
40	A2	change	7.8 points	1.91		104	hypothetical; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 139	not stated; safety; registry:adverse_events
	A2	events				10 / 143	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 139	not stated; modified itt; R0008264:Results
A1	events	1 / 139	not stated; randomized; registry:flow
A2	events	1 / 143	not stated; modified itt; R0008264:Results
A2	events	0 / 143	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	25.2	139	not stated; modified itt; R0008264:Results
A1	events		35 / 139	not stated; safety; registry:adverse_events
A2	events	18.9	143	not stated; modified itt; R0008264:Results
A2	events		27 / 143	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 139	not stated; safety; registry:adverse_events
	A2	events				14 / 143	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	22.3	139	not stated; modified itt; R0008264:Results
A1	events		31 / 139	not stated; safety; registry:adverse_events
A2	events	13.3	143	not stated; modified itt; R0008264:Results
A2	events		19 / 143	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 139	not stated; safety; registry:adverse_events
	A2	events				11 / 143	not stated; safety; registry:adverse_events