crossover randomized trial

NCT02773381

A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT02773381S001292

Design

Randomized: 15
Start year: 2016
Treatment: 12.43 weeks
Countries: United Kingdom (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 75; T2D on diet and exercise with or without metformin; HbA1c 6.0 to 9.0; BMI 20 to 38

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg	diet and exercise with or without metformin; lifestyle: not reported	15	15
A2	Placebo Placebo	diet and exercise with or without metformin; lifestyle: not reported	15	14

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	58.2
age	sd (years)	9.8
bmi	mean (kg/m2)	30.8
bmi	sd (kg/m2)	2.4
diabetes duration	mean (years)	3.1
diabetes duration	sd (years)	1.8
female	n	2
female	percent	13.3
hba1c	mean (percent)	6.9
hba1c	sd (percent)	1.1
metformin use	n	12
metformin use	percent	80.0
weight	mean (kg)	93.9
weight	sd (kg)	14.9
white	n	15
white	percent	100.0

Results

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

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-2.7 kg	3.6		13	not stated; other; R0023631:Table 1
12	A2	change	-0.1 kg	2.7		14	not stated; other; R0023631:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate					not stated; safety; R0023230:Supplement Table S9
	A2	rate					not stated; safety; R0023230:Supplement Table S9

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

Heart failure events (1 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 14	not stated; safety; R0023631:Supplement Table S3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				2 / 14	not stated; safety; R0023230:Supplement Table S9

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				1 / 14	not stated; safety; R0023230:Supplement Table S9

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				4 / 14	not stated; safety; R0023230:Supplement Table S9

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				2 / 14	not stated; safety; R0023230:Supplement Table S9

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0023230:Supplement Table S9
	A2	events				0 / 14	not stated; safety; R0023230:Supplement Table S9