parallel randomized trial

S003110

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

Other conditionsS003110

Design

Randomized: 24
Start year
Treatment
Countries: United States (1 sites)
Sponsor: (non industry)
Eligibility: severely burned children; no diabetes before the burn

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Intensive insulin Intensive insulin treatment	total enteral nutrition; lifestyle: standard	18	18
A2	exenatide Exenatide plus insulin if needed	total enteral nutrition; lifestyle: standard	6	6

Baseline characteristics

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

Characteristic	Statistic	Intensive insulin A1	Exenatide plus insulin if needed A2
age	mean (years)	12	12
age	sd (years)	4	5
weight	mean (kg)	41	49
weight	sd (kg)	19	23

Results

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

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; randomized; R0027200:Figure 1
	A2	events				0 / 6	not stated; randomized; R0027200:Figure 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; randomized; R0027200:Figure 1
	A2	events				0 / 6	not stated; randomized; R0027200:Figure 1

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0027200:Results
	A2	events				0 / 6	not stated; safety; R0027200:Results