parallel randomized trial

S002946

Design

Randomized: 32
Start year: 2020
Treatment: 26 weeks, follow-up 26 weeks
Countries: Japan (1 sites)
Sponsor: (not reported)
Eligibility: age over 20; T2D on liraglutide 0.6 or 0.9 mg; no new diabetes drug for 3 months

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide	prior liraglutide stopped; other drugs unchanged, mostly metformin; lifestyle: standard	16
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide	prior liraglutide stopped; other drugs unchanged, mostly metformin; lifestyle: standard	16

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	Dulaglutide 0.75 mg subcutaneous once weekly A2
age	mean (years)	61.5	62.7
age	sd (years)	11.2	12.0
bmi	mean (kg/m2)	27.0	25.1
bmi	sd (kg/m2)	6.6	3.9
diabetes duration	mean (years)	13.4	11.1
diabetes duration	sd (years)	10.6	12.0
egfr	mean (mL/min/1.73 m2)	73.9	58.6
egfr	sd (mL/min/1.73 m2)	21.4	16.7
hba1c	mean (percent)	6.4	6.5
hba1c	sd (percent)	0.8	0.6
insulin use	n	1	1
other background: drug naive	n	2	2
other background: insulin degludec and metformin and sglt2i	n	1	0
other background: insulin glargine only	n	0	1
other background: metformin and sglt2i	n	0	2
other background: metformin only	n	13	11
other male	percent	68.8	93.8
sbp	mean (mmHg)	129.3	132.4
sbp	sd (mmHg)	18.3	13.2
uacr	mean (mg/g)	38.7	234.7
uacr	sd (mg/g)	36.7	574.2
weight	mean (kg)	72.3	72.7
weight	sd (kg)	20.2	14.9

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Detail
26	A1	final	6.1 percent	0.5	not stated; other; R0006360:Table 2
26	A1	change	-0.42 percent	0.49	not stated; other; R0006360:Results
26	A2	change	-0.00 percent	0.34	not stated; other; R0006360:Results
26	A2	final	6.5 percent	0.5	not stated; other; R0006360:Table 2

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Detail
26	A1	change	-2.6 kg	3.6	not stated; other; R0006360:Results
26	A1	final	70.8 kg	21.5	not stated; other; R0006360:Table 2
26	A2	final	74.3 kg	14.5	not stated; other; R0006360:Table 2
26	A2	change	-0.1 kg	2.7	not stated; other; R0006360:Results

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 16	not stated; randomized; R0006360:Supplement Table S2
A1	events	0 / 16	not stated; randomized; R0006360:Supplement Table S2
A2	events	0 / 16	not stated; randomized; R0006360:Supplement Table S2
A2	events	0 / 16	not stated; randomized; R0006360:Supplement Table S2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	final	128.3 mmHg	11.9			not stated; other; R0006360:Table 2
26	A2	final	130.7 mmHg	16.6			not stated; other; R0006360:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	final	26.7 points	4.8		16	not stated; other; R0006360:Table 3
26	A2	final	29.5 points	8.0		15	not stated; other; R0006360:Table 3

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 16	not stated; randomized; R0006360:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				1 / 16	not stated; randomized; R0006360:Supplement Table S2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				2 / 16	not stated; randomized; R0006360:Supplement Table S2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2
	A2	events				0 / 16	not stated; randomized; R0006360:Supplement Table S2