parallel randomized trial

S003065

Design

Randomized: 64
Start year: 2017
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (2 sites)
Sponsor: Yokohama City University Hospital (non industry)
Eligibility: age 20 to 80; stable insulin therapy; HbA1c 7.0 to 9.5; C-peptide criteria; eGFR 30 or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	liraglutide Liraglutide 0.9 mg added to insulin	ongoing insulin with or without oral drugs; lifestyle: none		30
A2	Empagliflozin Empagliflozin 10 mg added to insulin	ongoing insulin with or without oral drugs; lifestyle: none		31

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

Characteristic	Statistic	Liraglutide 0.9 mg added to insulin A1	Empagliflozin A2
age	mean (years)	67.2	66.3
age	sd (years)	9.0	9.5
bmi	mean (kg/m2)	26.4	25.8
bmi	sd (kg/m2)	4.6	4.1
diabetes duration	mean (years)	18.8	19.0
diabetes duration	sd (years)	9.9	10.1
egfr	mean (mL/min/1.73 m2)	63.3	67.1
egfr	sd (mL/min/1.73 m2)	18.9	22.4
hba1c	mean (percent)	8.04	8.08
hba1c	sd (percent)	0.75	0.76
insulin dose	mean (U/day)	26.2	28.3
insulin dose	sd (U/day)	17.3	16.2
metformin use	n	8	15
metformin use	percent (percent)	26.7	48.4
other background: basal supported oral therapy	n	6	7
other background: basal supported oral therapy	percent	20.0	22.6
other background: multiple daily injection	n	24	24
other background: multiple daily injection	percent	80.0	77.4
other male	n	21	21
other male	percent (percent)	70.0	67.7
sbp	mean (mmHg)	140.4	137.2
sbp	sd (mmHg)	17.9	16.9
uacr	median (mg/g)	52.9	66.6
uacr	q1 (mg/g)	15.7	20.7
uacr	q3 (mg/g)	505.5	134.2
waist	mean (cm)	92.7	90.5
waist	se (cm)	2.3	2.0
weight	mean (kg)	70.1	69.0
weight	sd (kg)	14.4	16.0

18 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	-1.24 percent	0.15	30	not stated; full analysis; R0023921:Table 2
24	A1	final	6.80 percent	0.14	30	not stated; full analysis; R0023921:Table 2
24	A2	change	-0.35 percent	0.11	31	not stated; full analysis; R0023921:Table 2
24	A2	final	7.73 percent	0.14	31	not stated; full analysis; R0023921:Table 2

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-1.3 kg	0.4	30	not stated; full analysis; R0023921:Table 2
24	A1	final	68.9 kg	2.6	30	not stated; full analysis; R0023921:Table 2
24	A2	change	-1.5 kg	0.3	31	not stated; full analysis; R0023921:Table 2
24	A2	final	67.5 kg	3.0	31	not stated; full analysis; R0023921: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 / 30	not stated; full analysis; R0023921:Results
	A2	events				0 / 31	not stated; full analysis; R0023921:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	1.5	0.7			not stated; full analysis; R0023921:Table 2
	A2	rate	1.8	0.6			not stated; full analysis; R0023921:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-4.9 mmHg	2.7		30	not stated; full analysis; R0023921:Table 2
24	A2	change	-1.4 mmHg	2.7		31	not stated; full analysis; R0023921:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; full analysis; R0023921:Results
	A2	events				0 / 31	not stated; full analysis; R0023921:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 30	not stated; full analysis; R0023921:Results
	A2	events				0 / 31	not stated; full analysis; R0023921:Results