parallel randomized trial

S003083

Design

Randomized: 96
Start year: 2020
Treatment: 12 weeks, follow-up 12 weeks
Countries: China (1 sites)
Sponsor: (non industry)
Eligibility: age 18 to 65; BMI 28 or more; HbA1c 6.5 percent or more; on glucose lowering drugs

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	liraglutide Study group (liraglutide)	original glucose lowering drugs continued; lifestyle: not reported	48	47
A2	Lifestyle intervention (randomized arm) Lifestyle intervention	prior glucose lowering drugs continued; lifestyle: intensive	48	38

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

Characteristic	Statistic	Study group (liraglutide) A1	Lifestyle intervention (randomized arm) A2
age	mean (years)	51.53	49.97
age	sd (years)	9.11	11.44
bmi	mean (kg/m2)	31.12	32.68
bmi	sd (kg/m2)	4.06	3.80
diabetes duration	median (years)	2	3
diabetes duration	q1 (years)	0	0
diabetes duration	q3 (years)	6.25	8
female	percent	51.10	65.80
hba1c	mean (percent)	8.40	7.86
hba1c	sd (percent)	1.83	0.83
insulin use	n	8	4
insulin use	percent	17.00	10.50
metformin use	n	30	21
metformin use	percent	63.80	55.30
other agi use	n	16	7
other agi use	percent	34.00	18.40
other insulin secretagogue use	n	4	2
other insulin secretagogue use	percent	8.50	5.30
other insulin sensitizer use	n	2	1
other insulin sensitizer use	percent	4.30	2.60
sglt2i use	n	7	10
sglt2i use	percent	14.90	26.30
waist	mean (cm)	105.98	106.74
waist	sd (cm)	10.95	9.72
weight	mean (kg)	87.27	89.37
weight	sd (kg)	14.45	14.71

19 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
12	A1	change	-1.57 percent	2.00		47	not stated; completers; R0022816:Table 3
12	A2	change	-0.78 percent	1.03		38	not stated; completers; R0022816:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-3.06 kg	4.15		47	not stated; completers; R0022816:Table 3
12	A2	change	-1.83 kg	3.83		38	not stated; completers; R0022816:Table 3

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 47	not stated; completers; R0022816:Results
A1	events	0 / 47	not stated; completers; R0022816:Results
A1	events	0 / 47	not stated; completers; R0022816:Results
A2	events	0 / 38	not stated; completers; R0022816:Results
A2	events	0 / 38	not stated; completers; R0022816:Results
A2	events	0 / 38	not stated; completers; R0022816: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				47	not stated; completers; R0022816:Results
	A2	rate				38	not stated; completers; R0022816:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 48	not stated; randomized; intolerance to injection; R0022816:Figure 1
A2	events	0 / 48	not stated; randomized; R0022816:Figure 1
A2	events	0 / 48	not stated; randomized; R0022816:Figure 1

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 47	not stated; completers; R0022816:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 47	not stated; completers; R0022816:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 48	not stated; randomized; R0022816:Figure 1
	A2	events				0 / 48	not stated; randomized; R0022816:Figure 1