crossover randomized trial

S003438

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)S003438

Design

Randomized
Start year: 2021
Treatment: 0.03 weeks, follow-up 0.14 weeks
Countries: Netherlands (1 sites)
Sponsor: (non industry)
Eligibility: men of European descent aged 40 to 75; HbA1c 6.0 to 10.0 percent; eGFR above 60; metformin with or without sulfonylurea

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Intravenous sodium load Intravenous sodium load	metformin with or without sulfonylurea; lifestyle: standard	11
A2	Placebo Oral sodium load with placebo	oral sodium load 150 mmol in 300 mL broth; lifestyle: standard	11
A3	exenatide Oral sodium load with exenatide	oral sodium load 150 mmol in 300 mL broth; lifestyle: standard	11

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	60
age	sd (years)	5
bmi	mean (kg/m2)	31.9
bmi	sd (kg/m2)	3.9
diabetes duration	mean (years)	10.6
diabetes duration	sd (years)	6.3
egfr	mean (mL/min/1.73 m2)	89
egfr	sd (mL/min/1.73 m2)	5
hba1c	mean (percent)	7.5
hba1c	sd (percent)	0.9
metformin use	n	11
metformin use	percent	100
other normoalbuminuria	n	11
other normoalbuminuria	percent	100
other sulfonylurea use	n	2
other sulfonylurea use	percent	18
sbp	mean (mmHg)	127
sbp	sd (mmHg)	22
weight	mean (kg)	104.1
weight	sd (kg)	12.6

Results

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

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Detail
0.14	A1	final	132 mmHg	14	not stated; other; R0029290:Table 3
0.14	A1	final	113 mmHg	13	not stated; other; R0029290:Table 3
0.14	A2	final	128 mmHg	16	not stated; other; R0029290:Table 3
0.14	A2	final	111 mmHg	16	not stated; other; R0029290:Table 3
0.14	A3	final	130 mmHg	12	not stated; other; R0029290:Table 3
0.14	A3	final	115 mmHg	13	not stated; other; R0029290:Table 3