parallel randomized trial

S003023

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Type 2 diabetes (adults)S003023

Design

Randomized
Start year
Treatment: 0.43 weeks
Countries: Thailand (1 sites)
Sponsor: Faculty of Medicine, Chulalongkorn University (non industry)
Eligibility: age 20 to 80, T2D not on insulin, elective CABG or valve surgery with cardiopulmonary bypass

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: exclusion of participants without CGM data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg injection Group 1 liraglutide plus insulin infusion	perioperative insulin infusion by institutional protocol, oral agents stopped on surgery morning; lifestyle: none		32
A2	Standard care or no added treatment Group 2 insulin infusion only	perioperative insulin infusion by institutional protocol, oral agents stopped on surgery morning; lifestyle: none		28

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 1.2 mg injection A1	Standard care or no added treatment A2
age	mean (years)	68.1	63.2
bmi	mean (kg/m2)	24.5	24.6
established cvd: cerebrovascular accident	n	9	6
established cvd: cerebrovascular accident	percent	28.1	21.4
established cvd: heart failure	n	11	15
established cvd: heart failure	percent	34.3	53.6
established cvd: ischemic heart disease	n	22	23
established cvd: ischemic heart disease	percent	68.7	82.1
hba1c	mean (percent)	7.2	6.9
lvef	mean (percent)	48.4	53.8
metformin use	n	16	14
metformin use	percent	50	50
other chf	n	11	15
other chf	percent	34.3	53.6
other creatinine gt 2	n	8	8
other creatinine gt 2	percent	25.0	28.6
other cva	n	9	6
other cva	percent	28.1	21.4
other diet control only	n	1	2
other diet control only	percent	3.1	7.1
other ihd	n	22	23
other ihd	percent	68.7	82.1
other male	n	21	18
other male	percent	65.6	64.3
other more than two oral agents	n	5	1
other more than two oral agents	percent	15.6	3.6
other one oral agent	n	16	13
other one oral agent	percent	50	46.4
other two oral agents	n	10	12
other two oral agents	percent	31.2	42.8

Analyses this trial contributes to

Results

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

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; modified itt; R0017408:Results
	A2	events				0 / 28	not stated; modified itt; R0017408:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; modified itt; R0017408:Table 5
	A2	events				1 / 28	not stated; modified itt; R0017408:Table 5

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 32	not stated; modified itt; R0017408:Results
	A2	events				0 / 28	not stated; modified itt; R0017408:Table 5

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 32	not stated; modified itt; R0017408:Results
	A2	events				0 / 28	not stated; modified itt; R0017408:Table 5