parallel randomized trial

S003009

Design

Randomized: 88
Start year: 2023
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: Jiangsu Hansoh Pharmaceutical Group (industry)
Eligibility: age 18 or more; HbA1c 7.0 to 10.0 percent; eGFR 30 to 90; UACR above 30 to 5000 mg/g

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly PEG-loxenatide 0.2 mg	existing glucose lowering regimen; lifestyle: not reported	44	40
A2	Dapagliflozin Dapagliflozin 10 mg	existing glucose lowering regimen; lifestyle: not reported	44	40

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

Characteristic	Statistic	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly A1	Dapagliflozin A2
age	mean (years)	51.0	48.4
age	sd (years)	9.3	10.1
bmi	mean (kg/m2)	26.4	26.3
bmi	sd (kg/m2)	1.4	1.6
diabetes duration	mean (years)	7.8	7.3
diabetes duration	sd (years)	3.9	3.7
egfr	mean (mL/min/1.73 m2)	68.2	67.9
egfr	sd (mL/min/1.73 m2)	9.3	12.3
female	n	22	17
female	percent	55.0	42.5
hba1c	mean (percent)	8.31	8.31
hba1c	sd (percent)	0.71	0.77
insulin use	n	20	20
insulin use	percent	50.0	50.0
metformin use	n	20	23
metformin use	percent	50.0	57.5
other agi use	n	23	20
other agi use	percent	57.5	50.0
other su glinide use	n	12	13
other su glinide use	percent	30.0	32.5
other tzd use	n	12	18
other tzd use	percent	30.0	45.0
sbp	mean (mmHg)	137.1	135.7
sbp	sd (mmHg)	13.6	14.1
uacr	median (mg/g)	108.5	106.5
uacr	q1 (mg/g)	79.3	77.0
uacr	q3 (mg/g)	150.8	197.3
weight	mean (kg)	75.6	77.2
weight	sd (kg)	10.6	8.1

33 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
24	A1	change	-1.30 percent		-1.43 to -1.18	40	not stated; completers; R0011381:Table 2
24	A1	final	7.01 percent	0.50		40	not stated; completers; R0011381:Table 2
24	A1 vs A2	md	-0.01 percent		-0.19 to 0.17		not stated; completers; R0011381:Table 2
24	A2	change	-1.29 percent		-1.42 to -1.17	40	not stated; completers; R0011381:Table 2
24	A2	final	7.01 percent	0.69		40	not stated; completers; R0011381:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-3.9 kg		-4.7 to -3.1	40	not stated; completers; R0011381:Table 2
24	A1	final	71.8 kg	9.3		40	not stated; completers; R0011381:Table 2
24	A1 vs A2	md	-0.8 kg		-1.9 to 0.3		not stated; completers; R0011381:Table 2
24	A2	change	-3.1 kg		-3.9 to -2.3	40	not stated; completers; R0011381:Table 2
24	A2	final	74.1 kg	7.9		40	not stated; completers; R0011381:Table 2

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 40	not stated; completers; R0011381:Table 4
A1	events	0 / 40	not stated; completers; R0011381:Table 4
A1	events	1 / 40	not stated; completers; R0011381:Table 4
A2	events	0 / 40	not stated; completers; R0011381:Table 4
A2	events	0 / 40	not stated; completers; R0011381:Table 4
A2	events	1 / 40	not stated; completers; R0011381:Table 4

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-7.2 mmHg		-9.1 to -5.4	40	not stated; completers; R0011381:Table 2
24	A1	final	129.6 mmHg	9.17		40	not stated; completers; R0011381:Table 2
24	A1 vs A2	md	-2.6 mmHg		-5.3 to 0.0		not stated; completers; R0011381:Table 2
24	A2	change	-4.6 mmHg		-6.5 to -2.7	40	not stated; completers; R0011381:Table 2
24	A2	final	131.4 mmHg	10.7		40	not stated; completers; R0011381:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 40	not stated; completers; R0011381:Table 4
	A2	events				0 / 40	not stated; completers; R0011381:Table 4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 40	not stated; completers; R0011381:Table 4
	A2	events				1 / 40	not stated; completers; R0011381:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 40	not stated; completers; R0011381:Table 4
	A2	events				1 / 40	not stated; completers; R0011381:Table 4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 40	not stated; completers; R0011381:Table 4
	A2	events				0 / 40	not stated; completers; R0011381:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 40	not stated; completers; R0011381:Table 4
	A2	events				0 / 40	not stated; completers; R0011381:Table 4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 40	not stated; completers; R0011381:Table 4
	A2	events				1 / 40	not stated; completers; R0011381:Table 4