parallel randomized trial

S003027

Design

Randomized: 40
Start year: 2020
Treatment: 2.14 weeks, follow-up 2.14 weeks
Countries: Japan (1 sites)
Sponsor: (non industry)
Eligibility: age 20 to 80; HbA1c 7.0 to below 11.0 percent; insulin and GLP-1 RA naive on oral agents

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	insulin glargine and lixisenatide (iGlarLixi) and insulin glulisine iGlarLixi plus insulin glulisine	oral agents continued unchanged; DPP-4 inhibitor stopped; lifestyle: standard	20	20
A2	Basal bolus insulin Multiple daily injections (Gla-300 plus glulisine)	oral agents continued unchanged; lifestyle: standard	20	20

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

Characteristic	Statistic	iGlarLixi plus insulin glulisine A1	Basal bolus insulin A2
age	mean (years)	66.5	67.0
age	sd (years)	8.6	9.4
bmi	mean (kg/m2)	27.4	26.8
bmi	sd (kg/m2)	5.5	4.4
diabetes duration	mean (years)	11.7	11.4
diabetes duration	sd (years)	8.8	9.1
egfr	mean (mL/min/1.73 m2)	64.9	64.8
egfr	sd (mL/min/1.73 m2)	24.4	22.7
female	n	13	9
hba1c	mean (percent)	8.3	8.8
hba1c	sd (percent)	1.0	1.2
metformin use	n	13	11
other agi use	n	1	0
other dpp4i use	n		8
sglt2i use	n	9	8

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
2.14	A1	change	-0.7 percent	0.5	10	not stated; other; background:no_prior_dpp4i; R0016519:Supplement Table S3
2.14	A1	change	-0.6 percent	0.3	10	not stated; other; background:prior_dpp4i; R0016519:Supplement Table S3
2.14	A1	final	7.7 percent	0.8	20	not stated; other; R0016519:Table 3
2.14	A1	change	-0.6 percent	0.4	20	not stated; other; R0016519:Table 2
2.14	A2	final	8.0 percent	1.1	20	not stated; other; R0016519:Table 3
2.14	A2	change	-0.8 percent	0.5	20	not stated; other; R0016519:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0016519:Results
	A2	events				0 / 20	not stated; safety; R0016519:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 20	not stated; safety; R0016519:Results
A1	events	0 / 20	not stated; safety; R0016519:Results
A2	events	0 / 20	not stated; safety; R0016519:Results
A2	events	0 / 20	not stated; safety; R0016519:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 20	not stated; safety; loose stools and mild nausea; R0016519: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 / 20	not stated; safety; R0016519:Results
	A2	events				0 / 20	not stated; safety; R0016519:Results