parallel randomized trial

S003152

Design

Randomized: 360
Start year: 2019
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: age 18 or more; BMI 24 or more; HbA1c 7.0 percent or more; metformin 1500 mg/d or more alone or with premixed insulin

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide	metformin with or without premixed insulin; lifestyle: standard	180	143
A2	Dapagliflozin Dapagliflozin	metformin with or without premixed insulin; lifestyle: standard	180	166

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Dapagliflozin A2
age	mean (years)	51.9	51.8
age	sd (years)	11.1	11.4
bmi	mean (kg/m2)	30.2	29.6
bmi	sd (kg/m2)	4.3	4.2
diabetes duration	mean (years)	6.5	6.1
diabetes duration	sd (years)	5.8	5.5
established cvd	n	29	26
established cvd	percent	20.3	15.7
hba1c	mean (percent)	8.92	8.80
hba1c	sd (percent)	1.49	1.41
other male	n	83	107
other male	percent	58.0	64.5
other sulfonylurea use	n	40	51
other sulfonylurea use	percent	28.0	30.7
sbp	mean (mmHg)	143.9	144.1
sbp	sd (mmHg)	22.5	19.1
weight	mean (kg)	85.5	84.3
weight	sd (kg)	14.5	15.0

21 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	95% CI	Events / N	Detail
24	A1	change	-2.14 percent		-2.45 to -1.85	143	not stated; completers; R0022648:Table 2
24	A1	final	6.78 percent	1.00		143	not stated; completers; R0022648:Table 2
24	A2	change	-1.78 percent		-2.01 to -1.55	166	not stated; completers; R0022648:Table 2
24	A2	final	7.02 percent	1.05		166	not stated; completers; R0022648:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.08 kg		-1.78 to 1.94	143	not stated; completers; R0022648:Table 3
24	A1	final	85.5 kg	16.4		143	not stated; completers; R0022648:Table 3
24	A2	change	-0.61 kg		-1.23 to 0.01	166	not stated; completers; R0022648:Table 3
24	A2	final	82.7 kg	12.9		166	not stated; completers; R0022648:Table 3

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	67.8			143	not stated; completers; R0022648:Results
24	A2	responders	62.7			166	not stated; completers; R0022648:Results

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; other; R0022648:Results
A1	events	21 / 143	not stated; completers; R0022648:Results
A2	events	0 /	not stated; other; R0022648:Results
A2	events	29 / 166	not stated; completers; R0022648:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-3.98 mmHg		-8.87 to 0.92	143	not stated; completers; R0022648:Table 3
24	A1	final	140.6 mmHg	23.7		143	not stated; completers; R0022648:Table 3
24	A2	change	-5.28 mmHg		-8.43 to -2.12	166	not stated; completers; R0022648:Table 3
24	A2	final	139.7 mmHg	16.2		166	not stated; completers; R0022648:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0022648:Results
	A2	events				0 /	not stated; other; R0022648:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				2 / 180	not stated; randomized; R0022648:Figure 1