parallel randomized trial

NCT01686945

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

Other conditions NCT01686945S000224

Design

Randomized: 107
Start year: 2012
Treatment: 10 weeks, follow-up 14.9 weeks
Countries: Germany (1 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: males 18 to 64 y; healthy BMI 20 to 29.9; T2D BMI 20 to 37 and HbA1c 6.5 to 9.0

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
A1	semaglutide Healthy oral semaglutide 20 mg	lifestyle: not reported	16
A2	semaglutide Healthy oral semaglutide 40 mg	lifestyle: not reported	32
A3	Placebo Healthy placebo	lifestyle: not reported	18
A4	Placebo Healthy placebo with SNAC	lifestyle: not reported	18
A5	semaglutide T2D oral semaglutide 40 mg	diet and exercise with or without metformin; lifestyle: not reported	11
A6	Placebo T2D placebo	diet and exercise with or without metformin; lifestyle: not reported	6
A7	Placebo T2D placebo with SNAC	diet and exercise with or without metformin; lifestyle: not reported	6

Baseline characteristics

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

Characteristic	Statistic	T2D oral semaglutide 40 mg A5	Whole trial ALL
age cohort:healthy	mean (years)		44.7
age cohort:healthy	sd (years)		11.6
age cohort:t2d	mean (years)		54.5
age cohort:t2d	sd (years)		8.3
asian cohort:healthy	n		0
asian cohort:healthy	percent		0.0
asian cohort:t2d	n		0
asian cohort:t2d	percent		0.0
black cohort:healthy	n		1
black cohort:healthy	percent		1.2
black cohort:t2d	n		1
black cohort:t2d	percent		4.3
bmi cohort:healthy	mean (kg/m2)		25.9
bmi cohort:healthy	sd (kg/m2)		2.4
bmi cohort:t2d	mean (kg/m2)		29.4
bmi cohort:t2d	sd (kg/m2)		3.2
diabetes duration cohort:t2d	mean (years)		5.6
diabetes duration cohort:t2d	sd (years)		3.2
female cohort:healthy	percent		0
female cohort:t2d	percent		0
hba1c cohort:t2d	mean (percent)		7.5
hba1c cohort:t2d	sd (percent)		0.7
other male	n		107
other race other cohort:healthy	n		1
other race other cohort:healthy	percent		1.2
other race other cohort:t2d	n		0
other race other cohort:t2d	percent		0.0
sbp	mean (mmHg)	142
weight cohort:healthy	mean (kg)		83.5
weight cohort:healthy	sd (kg)		10.2
weight cohort:t2d	mean (kg)		94.9
weight cohort:t2d	sd (kg)		13.9
white cohort:healthy	n		82
white cohort:healthy	percent		97.6
white cohort:t2d	n		22
white cohort:t2d	percent		95.7

Results

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

HbA1c change (1 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A5 vs A6	md	-1.5 percent		-1.8 to -1.3		not stated; full analysis; R0016569:p9

Body weight change in kilograms (diabetes) (1 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A5 vs A6	md	-5.4 kg		-8.5 to -2.3		not stated; full analysis; R0016569:p9

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A5	events	0 / 11	not stated; safety; R0016569:p8
A5	events	0 / 11	not stated; safety; R0016569:Results
A6	events	0 / 6	not stated; safety; R0016569:Results
A6	events	0 / 6	not stated; safety; R0016569:p8
A7	events	0 / 6	not stated; safety; R0016569:Results
A7	events	0 / 6	not stated; safety; R0016569:p8

Systolic blood pressure change (1 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
10	A5 vs A6	md	-13 mmHg				not stated; full analysis; R0016569:p8

Serious adverse events (7 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 16	not stated; safety; R0016569:Table 3
A2	events	0 / 32	not stated; safety; R0016569:Table 3
A3	events	1 / 18	not stated; safety; R0016569:Table 3
A4	events	0 / 18	not stated; safety; R0016569:Table 3
A5	events	1 / 11	not stated; safety; R0016569:Table 3
A6	events	1 / 6	not stated; safety; R0016569:Table 3
A7	events	0 / 6	not stated; safety; R0016569:Table 3

Discontinuation due to adverse events (7 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 16	not stated; safety; R0016569:Results
A2	events	7 / 32	not stated; safety; R0016569:Results
A3	events	2 / 18	not stated; safety; R0016569:Results
A4	events	1 / 18	not stated; safety; R0016569:Results
A5	events	3 / 11	not stated; safety; R0016569:Results
A6	events	1 / 6	not stated; safety; R0016569:Results
A7	events	0 / 6	not stated; safety; R0016569:Results

Discontinuation due to gastrointestinal adverse events (7 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 16	not stated; safety; R0016569:Results
A2	events	3 / 32	not stated; safety; R0016569:Results
A3	events	1 / 18	not stated; safety; R0016569:Results
A4	events	0 / 18	not stated; safety; R0016569:Results
A5	events	1 / 11	not stated; safety; R0016569:Results
A6	events	0 / 6	not stated; safety; R0016569:Results
A7	events	0 / 6	not stated; safety; R0016569:Results