parallel randomized trial

S002900

Design

Randomized: 36
Start year: 2022
Treatment: 18 weeks, follow-up 18 weeks
Countries: Japan (1 sites)
Sponsor: (non industry)
Eligibility: T2D not at goal on diet, exercise and oral agents, criteria table S1 not stored

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	insulin glargine and lixisenatide (iGlarLixi) IGlarLixi	oral agents continued unchanged, DPP-4 inhibitors stopped; lifestyle: not reported	18	18
A2	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	oral agents continued unchanged, DPP-4 inhibitors stopped; lifestyle: not reported	18	18

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

Characteristic	Statistic	IGlarLixi A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated A2
age	mean (years)	63.2	61.1
age	sd (years)	11.0	14.4
bmi	mean (kg/m2)	26.2	27.8
bmi	sd (kg/m2)	3.8	5.4
diabetes duration	mean (years)	10.4	10.2
diabetes duration	sd (years)	6.8	8.9
egfr	mean (mL/min/1.73 m2)	67.2	75.7
egfr	sd (mL/min/1.73 m2)	20.1	17.6
female	n	8	4
hba1c	mean (percent)	8.5	8.8
hba1c	sd (percent)	0.9	1.2
metformin use	n	12	12
other alpha glucosidase inhibitor use	n	1	0
other dpp4i pretrial	n	11	8
other male	n	10	14
other male	percent	55.6	77.8
other sulfonylurea use	n	3	2
sglt2i use	n	12	9
weight	mean (kg)	67.4	75.7
weight	sd (kg)	13.8	16.8

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
18	A1	change	-1.5 percent	1.1	18	not stated; other; R0004556:Table 2
18	A1	final	7.0 percent	0.9	18	not stated; other; R0004556:Table 2
18	A2	change	-1.6 percent	1.3	18	not stated; other; R0004556:Table 2
18	A2	final	7.2 percent	0.6	18	not stated; other; R0004556:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
18	A1	change	-2.5 kg	2.7		18	not stated; other; R0004556:Table 2
18	A2	change	-1.8 kg	3.4		18	not stated; other; R0004556:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; randomized; R0004556:Results
	A2	events				0 / 18	not stated; randomized; R0004556:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 18	not stated; randomized; R0004556:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; randomized; R0004556:Results
	A2	events				0 / 18	not stated; randomized; R0004556:Results