parallel randomized trial

Combat-JUDO

A Parallel, Double-blinded, Randomized, 6 Months, Two Arms Study With Lifestyle Intervention and Bydureon® or Lifestyle Intervention and Placebo in Adolescents With Obesity to Explore Differences With Regard to Change in BMI SDS

Children and adolescents with obesity NCT02794402S001285

Design

Randomized: 44
Start year: 2015
Treatment: 26 weeks, follow-up 26 weeks
Countries: Sweden, Austria (2 sites)
Sponsor: Uppsala University (mixed)
Eligibility: age 10 to 17; age adapted BMI above 30 or BMI SDS above 2; no diabetes

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide extended release 2 mg	lifestyle: standard	22	22
A2	Placebo Placebo	lifestyle: standard	22	22

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	14.5	13.5
age	sd (years)	2.3	2.3
bmi sds	mean	3.1	3.0
bmi sds	sd	0.5	0.6
bmi	mean (kg/m2)	36.0	35.7
bmi	sd (kg/m2)	4.8	5.7
female	n	13	9
weight	mean (kg)	106.2	105.7
weight	sd (kg)	19.7	21.7

Results

4 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 / 22	not stated; randomized; R0002616:Results
	A2	events				0 / 22	not stated; randomized; R0002616:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 22	not stated; randomized; R0002616:Results
	A2	events				0 / 22	not stated; randomized; R0002616:Results