parallel randomized trial

S003148

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)Heart failure with LVEF 40 percent or lowerS003148

Design

Randomized: 559
Start year
Treatment: 52.14 weeks, follow-up 52.14 weeks
Countries: Italy (4 sites)
Sponsor: (non industry)
Eligibility: age 18 to 75; T2DM on non insulin drugs; LVEF below 35 percent; NYHA II to III; CRTd candidates

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	GLP-1 receptor agonist (liraglutide or lixisenatide) GLP-1 RA plus conventional therapy	conventional oral glucose lowering drugs; lifestyle: not reported		288
A2	Standard care or no added treatment Conventional hypoglycemic therapy (controls)	conventional non insulin glucose lowering drugs; CRTd; lifestyle: not reported		271

Baseline characteristics

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

Characteristic	Statistic	GLP-1 RA plus conventional therapy A1	Standard care or no added treatment A2
age	mean (years)	72	72
age	sd (years)	7	6
bmi: more than 30	n	18	17
bmi: more than 30	percent	6.2	6.3
established cvd: ischemic heart failure	n	195	186
established cvd: ischemic heart failure	percent	67.7	68.6
hba1c	mean (mmol/mol)	58.2	58.0
hba1c	sd (mmol/mol)	16.2	16.0
insulin use	n	33	30
insulin use	percent	11.5	11.1
lvef	mean (percent)	27	28
lvef	sd (percent)	6	4
metformin use	n	87	90
metformin use	percent	30.2	33.2
other ischemic heart failure	n	195	186
other ischemic heart failure	percent	67.7	68.6
other male	n	206	197
other male	percent	71.5	72.6
other renal disease	n	56	51
other renal disease	percent	19.4	18.9
other sulfonylurea use	n	56	53
other sulfonylurea use	percent	19.4	19.6
other tzd use	n	22	19
other tzd use	percent	7.6	7.1

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	final	54.1 mmol/mol	12.3	288	not stated; randomized; R0010953:Table 2
26.07	A2	final	54.0 mmol/mol	12.1	271	not stated; randomized; R0010953:Table 2
52.14	A1	final	52.7 mmol/mol	12.5	288	not stated; randomized; R0010953:Table 2
52.14	A2	final	53.1 mmol/mol	12.4	271	not stated; randomized; R0010953:Table 2

All cause mortality (4 lines; O20)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			19 / 288	not stated; randomized; R0010953:Table 3
A1 vs A2	hr	7.619	0.004 to 14.031		not stated; randomized; R0010953:Table 4
A1 vs A2	hr	2.373	1.087 to 5.182		not stated; randomized; R0010953:Table 4
A2	events			16 / 271	not stated; randomized; R0010953:Table 3

Hospitalization for heart failure (4 lines; O23)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			48 / 288	not stated; randomized; R0010953:Table 3
A1 vs A2	hr	0.119	0.028 to 0.508		not stated; randomized; R0010953:Table 4
A1 vs A2	hr	1.914	1.335 to 2.744		not stated; randomized; R0010953:Table 4
A2	events			76 / 271	not stated; randomized; R0010953:Table 3