parallel randomized trial

S002931

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

Other conditionsS002931

Design

Randomized: 278
Start year: 2017
Treatment: 0.14 weeks, follow-up 4.29 weeks
Countries: Netherlands (4 sites)
Sponsor: Academic Medical Center (industry)
Eligibility: age 18 to 80; elective cardiac surgery; no type 1 diabetes, insulin above 0.5 IU/kg daily or severe heart failure

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	liraglutide Liraglutide	elective cardiac surgery with intraoperative insulin bolus algorithm; lifestyle: not reported	139	129
A2	Placebo Placebo	elective cardiac surgery with intraoperative insulin bolus algorithm; lifestyle: not reported	139	132

Baseline characteristics

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

Characteristic	Statistic	Liraglutide A1	Placebo A2
age	mean (years)	64.6	65.3
age	sd (years)	11.2	10.7
bmi	mean (kg/m2)	27.3	27.7
bmi	sd (kg/m2)	4.0	4.4
hba1c	mean (percent)	5.8	5.8
hba1c	sd (percent)	0.9	0.8
other male	n	105	106
other male	percent	81	80
other race other	n	6	5
other race other	percent	5	4
other smoker	n	26	28
other smoker	percent	20	21
white	n	123	127
white	percent	95	96

Results

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

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 21	not stated; other; diabetes:t2d; R0012570:Appendix S1
A1	events	0 / 21	not stated; other; diabetes:t2d; R0012570:Appendix S1
A2	events	0 / 21	not stated; other; diabetes:t2d; R0012570:Appendix S1
A2	events	0 / 21	not stated; other; diabetes:t2d; R0012570:Appendix S1

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 129	not stated; modified itt; preoperative nausea; R0012570:Figure 2
A1	events	1 / 129	not stated; modified itt; hypoglycaemia (3.6 mmol/L); R0012570:Figure 2
A2	events	1 / 132	not stated; modified itt; preoperative nausea; R0012570:Figure 2

Nausea (12 lines; O27A)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			4 / 129	not stated; modified itt; nausea and vomiting; R0012570:Table 2
A1	events			4 / 21	not stated; other; diabetes:t2d; nausea and vomiting; R0012570:Appendix S1
A1	events			32 / 126	not stated; per protocol; nausea and vomiting; R0012570:Appendix S1
A1	events			33 / 129	not stated; modified itt; nausea and vomiting; R0012570:Table 2
A1	events			0 / 21	not stated; other; diabetes:t2d; nausea and vomiting; R0012570:Appendix S1
A2	events			27 / 132	not stated; modified itt; nausea and vomiting; R0012570:Table 2
A2	events			27 / 131	not stated; per protocol; nausea and vomiting; R0012570:Appendix S1
A2	events			1 / 132	not stated; modified itt; nausea and vomiting; R0012570:Table 2
A2 vs A1	rd	-5	-15 to 6		not stated; modified itt; nausea and vomiting; R0012570:Table 2
A2 vs A1	rd	-2	-6 to 1		not stated; modified itt; nausea and vomiting; R0012570:Table 2
A2	events			2 / 21	not stated; other; diabetes:t2d; nausea and vomiting; R0012570:Appendix S1
A2	events			1 / 21	not stated; other; diabetes:t2d; nausea and vomiting; R0012570:Appendix S1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 129	not stated; modified itt; preoperative nausea; R0012570:Figure 2
	A2	events				1 / 132	not stated; modified itt; preoperative nausea; R0012570:Figure 2