crossover randomized trial

S002997

Design

Randomized: 24
Start year: 2020
Treatment: 3.57 weeks, follow-up 3.57 weeks
Countries: Japan (1 sites)
Sponsor: (non industry)
Eligibility: age 20 to 80; T2D at least 1 year on oral agents or basal insulin; HbA1c 7.0 to 11.0 percent; inpatients

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira	oral agents continued unchanged; DPP4 inhibitors stopped; lifestyle: standard	24	24
A2	Premixed insulin IDegAsp	oral agents continued unchanged; DPP4 inhibitors stopped; lifestyle: standard	24	24

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	65.4
age	sd (years)	9.6
bmi	mean (kg/m2)	29.0
bmi	sd (kg/m2)	6.2
diabetes duration	mean (years)	12.8
diabetes duration	sd (years)	8.3
egfr	mean (mL/min/1.73 m2)	65.3
egfr	sd (mL/min/1.73 m2)	17.3
hba1c	mean (percent)	8.8
hba1c	sd (percent)	1.1
metformin use	n	21
other male	n	15
other male	percent	62.5
sglt2i use	n	15

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

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 24	not stated; randomized; loose stools; R0012621:Results
	A2	events				0 / 24	not stated; randomized; loose stools; R0012621:Results

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621: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 / 24	not stated; randomized; R0012621:Results
	A2	events				0 / 24	not stated; randomized; R0012621:Results