crossover randomized trial

NCT04189848

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

A Trial to Complare the Injection Site Pain Experience of Semaglutide 0.25 mg and Dulaglutide 0.75 mg Administered sc

Other conditions NCT04189848S000979

Design

Randomized: 104
Start year: 2019
Treatment: , follow-up 5 weeks
Countries: Netherlands (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 75; BMI 25 or higher; HbA1c below 6.5 percent; healthy

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: per protocol
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	semaglutide Semaglutide 0.25 mg single injection	lifestyle: none	104	104
A2	dulaglutide Dulaglutide 0.75 mg single injection	lifestyle: none	104	104

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)	37
age	sd (years)	17.5
asian	n	3
black	n	1
bmi	mean (kg/m2)	30
bmi	sd (kg/m2)	3.8
female	n	62
female	percent	60
hispanic	n	0
white	n	94