crossover randomized trial

NCT05435677

A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes

Type 2 diabetes (adults)NCT05435677S001682

Design

Randomized: 20
Start year: 2022
Treatment
Countries: China (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: Chinese adults 18 to 64; T2D at least 180 days; insulin naive; HbA1c up to 9.0 percent; BMI 18.5 to 34.9

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	insulin icodec and semaglutide (IcoSema) IcoSema single dose	metformin in all, with or without other stable oral glucose lowering drugs; lifestyle: not reported	20	19
A2	Insulin icodec Insulin icodec single dose	metformin in all, with or without other stable oral glucose lowering drugs; lifestyle: not reported	20	20
A3	semaglutide Semaglutide single dose	metformin in all, with or without other stable oral glucose lowering drugs; lifestyle: not reported	20	20

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)	50.5
age	sd (years)	7.7
asian	n	20
asian	percent	100.0
bmi	mean (kg/m2)	26.2
bmi	sd (kg/m2)	2.6
diabetes duration	mean (years)	2.4
diabetes duration	sd (years)	1.6
female	n	12
female	percent	60.0
hba1c	mean (percent)	7.2
hba1c	sd (percent)	0.6
metformin use	n	20
metformin use	percent	100.0
other agi use	n	2
other agi use	percent	10.0
weight	mean (kg)	69.5
weight	sd (kg)	8.5

Results

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

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Results
A2	events	0 / 20	while on treatment; safety; R0003268:Results
A3	events	0 / 20	while on treatment; safety; R0003268:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Results
A2	events	0 / 20	while on treatment; safety; R0003268:Results
A3	events	0 / 20	while on treatment; safety; R0003268:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	1 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	2 / 20	while on treatment; safety; R0003268:Supplement Table S3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	2 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	4 / 20	while on treatment; safety; R0003268:Supplement Table S3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Results
A2	events	0 / 20	while on treatment; safety; R0003268:Results
A3	events	0 / 20	while on treatment; safety; R0003268:Results

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	while on treatment; safety; R0003268:Supplement Table S3
A2	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3
A3	events	0 / 20	while on treatment; safety; R0003268:Supplement Table S3