parallel randomized trial

NCT02064348

A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration

Other conditions NCT02064348S001221

Design

Randomized: 168
Start year: 2014
Treatment: 16 weeks, follow-up 23 weeks
Countries: Germany (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: healthy adults 18 to 55; BMI 20 to 30; weight 60 to 110 kg

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	semaglutide Semaglutide 1.5 mg	none; lifestyle: none		83
A2	Placebo Placebo	none; lifestyle: none		83

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 1.5 mg A1	Placebo A2
age	max (years)	55	55
age	mean (years)	37.7	38.6
age	min (years)	19	21
bmi	max (kg/m2)	30.0	29.9
bmi	mean (kg/m2)	24.9	25.2
bmi	min (kg/m2)	20.5	20.1
female	n	30	37
female	percent	36.1	44.6
weight	max (kg)	107.2	99.0
weight	mean (kg)	77.9	76.6
weight	min (kg)	58.9	59.5
white	n	78	82
white	percent	94.0	98.8

Results

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

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 83	not stated; safety; R0018853:Results
	A2	events				0 / 83	not stated; safety; R0018853:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 83	not stated; safety; R0018853:Results
	A2	events				4 / 83	not stated; safety; R0018853:Results