crossover randomized trial

NCT03789578

A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT03789578S000284

Design

Randomized: 31
Start year: 2019
Treatment: , follow-up 21.43 weeks
Countries: Germany (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 64; T2D on metformin with or without one oral drug; weight 80 to 120 kg; HbA1c 6.0 to 8.5 percent

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	insulin icodec and semaglutide IcoSema single dose	metformin; lifestyle: not reported	31	30
A2	Insulin icodec Insulin icodec single dose	metformin; lifestyle: not reported	31	28
A3	semaglutide Semaglutide single dose	metformin; lifestyle: not reported	31	28

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)	57.4
age	sd (years)	6.2
bmi	mean (kg/m2)	31.1
bmi	sd (kg/m2)	3.4
diabetes duration	mean (years)	9.5
diabetes duration	sd (years)	6.9
female	n	8
female	percent	25.8
hba1c	mean (percent)	7.2
hba1c	sd (percent)	0.6
metformin use	n	31
metformin use	percent	100.0
other dpp4i use	n	5
other dpp4i use	percent	16.1
sglt2i use	n	2
sglt2i use	percent	6.5
weight	mean (kg)	96.2
weight	sd (kg)	10.6
white	n	31
white	percent	100.0

Results

15 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 / 30	while on treatment; safety; R0004807:Results
A2	events	0 / 28	while on treatment; safety; R0004807:Results
A3	events	0 / 28	while on treatment; safety; R0004807:Results

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 30	while on treatment; safety; R0004807:Table 3
A2	events	1 / 28	while on treatment; safety; R0004807:Table 3
A3	events	0 / 28	while on treatment; safety; R0004807:Table 3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 30	while on treatment; safety; R0004807:Results
A2	events	0 / 28	while on treatment; safety; R0004807:Results
A3	events	0 / 28	while on treatment; safety; R0004807:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	14 / 30	while on treatment; safety; R0004807:Table 3
A2	events	0 / 28	while on treatment; safety; R0004807:Table 3
A3	events	6 / 28	while on treatment; safety; R0004807:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	11 / 30	while on treatment; safety; R0004807:Table 3
A2	events	0 / 28	while on treatment; safety; R0004807:Table 3
A3	events	2 / 28	while on treatment; safety; R0004807:Table 3