parallel randomized trial

S003039

Design

Randomized: 22
Start year: 2016
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan
Sponsor: (non industry)
Eligibility: T2D age 20 or older; HbA1c 6.5 percent or higher; liraglutide for at least 12 weeks; eGFR 30 or higher

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	dulaglutide Switch to dulaglutide	liraglutide stopped; other glucose lowering drugs and insulin unchanged; lifestyle: standard	11	11
A2	liraglutide Continue liraglutide	other glucose lowering drugs and insulin unchanged; lifestyle: standard	11	11

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

Characteristic	Statistic	Switch to dulaglutide A1	Continue liraglutide A2
age	mean (years)	69.2	67.8
age	sd (years)	9.1	9.5
bmi	mean (kg/m2)	26.7	25.9
bmi	sd (kg/m2)	4.4	3.6
diabetes duration	mean (years)	14.5	13.7
diabetes duration	sd (years)	8.9	8.2
egfr	mean (mL/min/1.73 m2)	71.5	76.6
egfr	sd (mL/min/1.73 m2)	18.0	19.2
established cvd	n	5	2
established cvd	percent	45.5	18.2
hba1c	mean (percent)	7.1	7.2
hba1c	sd (percent)	0.5	0.5
insulin use	n	3	8
insulin use	percent	27.3	72.7
metformin use	n	5	5
metformin use	percent	45.5	45.5
other agi use	n	5	1
other agi use	percent	45.5	9.1
other glinide use	n	0	1
other glinide use	percent	0.0	9.1
other male	n	9	4
other male	percent	81.8	36.4
other sulfonylurea use	n	1	0
other sulfonylurea use	percent	9.1	0.0
other thiazolidinedione use	n	1	1
other thiazolidinedione use	percent	9.1	9.1
sbp	mean (mmHg)	137.5	138.5
sbp	sd (mmHg)	17.5	19.1
sglt2i use	n	1	2
sglt2i use	percent	9.1	18.2
weight	mean (kg)	68.3	63.4
weight	sd (kg)	13.4	12.9

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	7.1 percent	0.6		11	not stated; completers; R0019432:Table 2
24	A2	final	7.6 percent	0.9		11	not stated; completers; R0019432:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	69.1 kg	14.0		11	not stated; completers; R0019432:Table 2
24	A2	final	64.4 kg	13.8		11	not stated; completers; R0019432:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	136.8 mmHg	20.2		11	not stated; completers; R0019432:Table 2
24	A2	final	131.6 mmHg	21.1		11	not stated; completers; R0019432:Table 2

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	30.00 points	5.60		11	not stated; completers; R0019432:Table 3
24	A2	final	26.36 points	3.98		11	not stated; completers; R0019432:Table 3