parallel randomized trial

S002937

Design

Randomized: 39
Start year: 2021
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (2 sites)
Sponsor: (non industry)
Eligibility: age 20 or older; T2D on dulaglutide 12 weeks or more; HbA1c 6.5 percent or more; eGFR above 30

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 0.5 mg subcutaneous once weekly Switch to semaglutide 0.5 mg weekly	prior glucose lowering drugs unchanged; lifestyle: standard	19	18
A2	Dulaglutide 0.75 mg subcutaneous once weekly Continue dulaglutide 0.75 mg weekly	prior glucose lowering drugs unchanged; lifestyle: standard	20	19

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)	72.2	71.8
age	sd (years)	9.7	11.3
bmi	mean (kg/m2)	29.4	27.3
bmi	sd (kg/m2)	4.8	6.5
diabetes duration	mean (years)	18.2	20.3
diabetes duration	sd (years)	11.1	10.7
egfr	mean (mL/min/1.73m2)	63.0	68.0
egfr	sd (mL/min/1.73m2)	21.6	18.5
hba1c	mean (percent)	7.7	7.4
hba1c	sd (percent)	0.7	0.6
insulin use	n	6	4
insulin use	percent	33.3	21.1
metformin use	n	9	14
metformin use	percent	50.0	73.7
other agi use	n	5	4
other agi use	percent	27.8	21.1
other glinide use	n	2	3
other glinide use	percent	11.1	15.8
other macroangiopathy	n	7	5
other macroangiopathy	percent	38.9	26.3
other male	n	12	8
other male	percent	66.7	42.1
other sulfonylurea use	n	3	3
other sulfonylurea use	percent	16.7	15.8
other tzd use	n	2	2
other tzd use	percent	11.1	10.5
sbp	mean (mmHg)	134.3	137.7
sbp	sd (mmHg)	16.5	18.8
sglt2i use	n	11	9
sglt2i use	percent	61.1	47.9
uacr	mean (mg/g)	104.7	115.1
uacr	sd (mg/g)	195.5	217.6
weight	mean (kg)	75.3	68.7
weight	sd (kg)	12.7	19.3

11 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	Events / N	Detail
24	A1	change	-0.4 percent	0.5	18	not stated; completers; R0006558:Results
24	A1	final	7.3 percent	0.6	18	not stated; completers; R0006558:Table 2
24	A2	change	0.2 percent	0.6	19	not stated; completers; R0006558:Results
24	A2	final	7.5 percent	0.8	19	not stated; completers; R0006558:Table 2

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	74.4 kg	11.7		18	not stated; completers; R0006558:Table 2
24	A2	final	68.2 kg	19.4		19	not stated; completers; R0006558:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	133.6 mmHg	24.2		18	not stated; completers; R0006558:Table 2
24	A2	final	141.5 mmHg	18.0		19	not stated; completers; R0006558: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
24	A1	final	26.4 points	7.1		18	not stated; completers; R0006558:Table 4
24	A2	final	28.2 points	7.8		19	not stated; completers; R0006558:Table 4

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 19	not stated; randomized; pain for injection; R0006558:Figure 2