crossover randomized trial

NCT02147431

A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT02147431S002097

Design

Randomized: 38
Start year: 2014
Treatment: 12 weeks
Countries: Austria (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 64; HbA1c 6.5 to 10.0 percent; BMI 20 to 35; metformin only

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: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	metformin; lifestyle: not reported	38	37
A2	Placebo Placebo	metformin; lifestyle: not reported	38	37

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	max (years)	64
age	mean (years)	54.2
age	min (years)	41
age	sd (years)	6.4
bmi	max (kg/m2)	36.1
bmi	mean (kg/m2)	29.4
bmi	min (kg/m2)	23.3
bmi	sd (kg/m2)	3.4
diabetes duration	max (years)	13.2
diabetes duration	mean (years)	4.5
diabetes duration	min (years)	0.3
diabetes duration	sd (years)	3.2
female	n	12
female	percent	32.4
hba1c	max (percent)	9.8
hba1c	mean (percent)	7.7
hba1c	min (percent)	6.2
hba1c	sd (percent)	1.0
weight	max (kg)	112.0
weight	mean (kg)	88.5
weight	min (kg)	66.2
weight	sd (kg)	11.1
white	n	37

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13	A1	change	-1.1 percent	0.7		38	not stated; other; R0025031:Supplement Table S3
13	A2	change	0.4 percent	0.8		37	not stated; other; R0025031:Supplement Table S3

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13	A1	change	-3.7 kg	2.7		38	not stated; other; R0025031:Supplement Table S3
13	A2	change	0.3 kg	2.8		37	not stated; other; R0025031:Supplement Table S3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 38	while on treatment; safety; R0025031:Supplement Table S4
A1	events	0 / 38	while on treatment; safety; R0025031:Supplement Table S4
A1	events	0 / 38	while on treatment; safety; R0025031:Supplement Table S4
A2	events	0 / 37	while on treatment; safety; R0025031:Supplement Table S4
A2	events	1 / 37	while on treatment; safety; R0025031:Supplement Table S4
A2	events	4 / 37	while on treatment; safety; R0025031:Supplement Table S4

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate					while on treatment; safety; R0025031:Supplement Table S4
	A2	rate					while on treatment; safety; R0025031:Supplement Table S4

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
13	A1	change	-8 mmHg	16			not stated; safety; R0025031:Results
13	A2	change	-3 mmHg	12			not stated; safety; R0025031:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 38	not stated; safety; R0025031:Results
	A2	events				0 / 37	not stated; safety; R0025031:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 38	while on treatment; safety; R0025031:Supplement Table S4
	A2	events				4 / 37	while on treatment; safety; R0025031:Supplement Table S4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 38	while on treatment; safety; R0025031:Supplement Table S4
	A2	events				2 / 37	while on treatment; safety; R0025031:Supplement Table S4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 38	while on treatment; safety; R0025031:Supplement Table S4
	A2	events				5 / 37	while on treatment; safety; R0025031:Supplement Table S4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 38	while on treatment; safety; R0025031:Supplement Table S4
	A2	events				0 / 37	while on treatment; safety; R0025031:Supplement Table S4

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 38	while on treatment; safety; R0025031:Supplement Table S4
	A2	events				7 / 37	while on treatment; safety; R0025031:Supplement Table S4

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 38	not stated; safety; R0025031:Results
	A2	events				0 / 37	not stated; safety; R0025031:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 38	not stated; safety; R0025031:Results
	A2	events				0 / 37	not stated; safety; R0025031:Results