parallel randomized trial

LOSEIT

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

Effect of Liraglutide on Body Weight and Pain in Overweight or Obese Patients With Knee Osteoarthritis: A Randomised, Double Blind, Placebo-controlled, Parallel Group, Single-centre Trial

Knee osteoarthritis NCT02905864S001734

Design

Randomized: 156
Start year: 2016
Treatment: 52 weeks, follow-up 52 weeks
Countries: Denmark (1 sites)
Sponsor: Henrik Gudbergsen (industry)
Eligibility: age 18 to 74; BMI 27 or more; knee OA KL grade 1 to 3; at least 5% weight loss after diet run in

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg	tapering diet with meal replacements weeks 0 to 8, then 1500 kcal/day target; lifestyle: intensive	80
A2	Placebo Placebo	tapering diet with meal replacements weeks 0 to 8, then 1500 kcal/day target; lifestyle: intensive	76

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	58.8	58.6
age	sd (years)	11.3	9.6
bmi	mean (kg/m2)	33.0	31.5
bmi	sd (kg/m2)	5.9	4.1
female	n	43	44
female	percent	65.1	63.8
weight	mean (kg)	97.1	91.6
weight	sd (kg)	19.0	14.4