parallel randomized trial

NCT02146079

A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Other conditions NCT02146079S001888

Design

Randomized: 44
Start year: 2014
Treatment: 13 weeks, follow-up 18 weeks
Countries: Japan (1 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: healthy Japanese or Caucasian men 20 to 55, BMI 20 to 25, HbA1c 6.0 percent or less

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide 0.5 mg	lifestyle: none
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	lifestyle: none
A3	Placebo Placebo	lifestyle: none	12

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 0.5 mg subcutaneous once weekly A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Placebo A3	Whole trial ALL
age race:caucasian	max (years)	52	51	49
age race:caucasian	mean (years)	33.4	35.0	36.5
age race:caucasian	min (years)	26	25	26
age race:japanese	max (years)	44	47	51
age race:japanese	mean (years)	34.1	39.1	41.4
age race:japanese	min (years)	23	29	27
asian: japanese	n	8	8	6
asian	n	8	8	6
bmi race:caucasian	max (kg/m2)	24.9	24.5	24.5
bmi race:caucasian	mean (kg/m2)	22.9	22.1	22.6
bmi race:caucasian	min (kg/m2)	21.2	20.0	20.0
bmi race:japanese	max (kg/m2)	24.7	24.5	23.6
bmi race:japanese	mean (kg/m2)	22.3	21.4	21.7
bmi race:japanese	min (kg/m2)	20.0	20.1	20.4
other male	n				44
weight race:caucasian	max (kg)	86.0	86.6	73.8
weight race:caucasian	mean (kg)	74.9	73.5	69.8
weight race:caucasian	min (kg)	66.5	61.4	62.9
weight race:japanese	max (kg)	68.9	74.3	67.9
weight race:japanese	mean (kg)	63.9	64.3	62.4
weight race:japanese	min (kg)	58.6	55.3	56.8
white	n	8	8	6

Results

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

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; safety; R0020993:Results
A2	events	0 /	not stated; safety; R0020993:Results
A3	events	0 / 12	not stated; safety; R0020993:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; safety; R0020993:Results
A2	events	0 /	not stated; safety; R0020993:Results
A3	events	0 / 12	not stated; safety; R0020993:Results

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 /	not stated; safety; R0020993:Results
A2	events	0 /	not stated; safety; R0020993:Results
A3	events	0 / 12	not stated; safety; R0020993:Results