factorial randomized trial

S003026

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

Other conditionsS003026

Design

Randomized: 1,400
Start year: 2016
Treatment: , follow-up 433.09 weeks
Countries: Denmark (1 sites)
Sponsor: Lars Kober, Rigshospitalet (non industry)
Eligibility: adults 18 years or older, elective or subacute CABG and/or AVR with CPB

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide Exenatide	lifestyle: not reported		695
A2	Placebo Placebo	lifestyle: not reported		694

Baseline characteristics

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

Characteristic	Statistic	Exenatide A1	Placebo A2
age	median (years)	68	68
age	q1 (years)	61	60
age	q3 (years)	74	73
bmi	median (kg/m2)	27.1	27.1
bmi	q1 (kg/m2)	25	25
bmi	q3 (kg/m2)	30	30
female	n	119	114
female	percent	17	16
insulin use	n	35	31
insulin use	percent	5.1	4.5
white	n	673	685
white	percent	98	99

Results

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

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				33 / 695	not stated; modified itt; R0015030:Table 3
	A2	events				37 / 694	not stated; modified itt; R0015030:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 695	not stated; modified itt; pancreatitis; R0015030:Table 3
	A2	events				1 / 694	not stated; modified itt; pancreatitis; R0015030:Table 3