parallel randomized trial

S003100

Design

Randomized: 90
Start year: 2019
Treatment: 13.04 weeks, follow-up 13.04 weeks
Countries: China (2 sites)
Sponsor: (non industry)
Eligibility: age 18 to 75; T2D; OSA with AHI above 15 on CPAP; no DPP4i or GLP-1 RA

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide plus CPAP and usual drugs	CPAP; usual glucose lowering drugs; lifestyle: not reported	45	44
A2	Standard care or no added treatment Control, CPAP and usual drugs without liraglutide	CPAP and usual glucose lowering drugs, adjustable; lifestyle: not reported	45	45

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Standard care or no added treatment A2
age	mean (years)	55.7	54.8
age	sd (years)	7.4	5.5
ahi	mean (events/h)	31.0	30.1
ahi	sd (events/h)	7.3	6.22
bmi	mean (kg/m2)	26.5	27.0
bmi	sd (kg/m2)	4.4	2.4
hba1c	mean (percent)	6.64	6.64
hba1c	sd (percent)	0.61	0.50
insulin use	n	9	14
lvef	mean (percent)	63.8	63.5
lvef	sd (percent)	5.70	4.2
metformin use	n	34	36
other alpha glucosidase inhibitor use	n	12	15
other male	n	34	29
other sulfonylurea use	n	19	22
other thiazolidinedione use	n	7	9
sbp	mean (mmHg)	130.4	132.2
sbp	sd (mmHg)	11.9	13.0
sglt2i use	n	6	8

13 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
13.04	A1	final	6.41 percent	0.61		44	not stated; completers; R0021058:Table 4
13.04	A2	final	6.57 percent	0.50		45	not stated; completers; R0021058:Table 4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 44	not stated; completers; R0021058:Table 5
	A2	events				1 / 45	not stated; completers; R0021058:Table 5

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13.04	A1	final	124.8 mmHg	12.5		44	not stated; completers; R0021058:Table 4
13.04	A2	final	131.0 mmHg	13.0		45	not stated; completers; R0021058:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 45	not stated; randomized; R0021058:Results
	A2	events				0 / 45	not stated; randomized; R0021058:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 45	not stated; randomized; nausea and vomiting; R0021058:Methods
	A2	events				0 / 45	not stated; randomized; R0021058:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 44	not stated; completers; pancreatitis; R0021058:Results

Apnea hypopnea index change (2 lines; O70)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13.04	A1	final	26.1 events/h	7.1		44	not stated; completers; R0021058:Table 3
13.04	A2	final	31.6 events/h	6.9		45	not stated; completers; R0021058:Table 3