Diabetes Mellitus, Type 2Phase 1NCT05435677

A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

A Phase 1 study testing IcoSema, insulin icodec and semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes. IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide. Insulin icodec is a possible new medicine. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: IcoSema, insulin icodec and semaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 22 Jun 2022to 25 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Chinese male or female
Aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
Body weight greater than or equal to 50 kg
HbA1c (glycated haemoglobin) below or equal to 9.0% (75 mmol/mol)

Show all 13Show fewer

Insulin naïve. However, short-term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) including any of the following anti-diabetic drug(s)/regimen within 45 days prior to the day of screening:
Any metformin formulation
DPP-4 (dipeptidyl peptidase-4) inhibitors (participants are not allowed to participate in the study if they are treated with DPP-4 inhibitors as monotherapy)
SGLT2 (sodium-glucose linked transporter 2) inhibitors
Alpha-glucosidase inhibitors
Oral combination products (for the allowed individual oral antidiabetic drugs)

Who cannot join

Known or suspected hypersensitivity to trial product(s) or related products
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital, Northern branch-Phase I
Beijing, Beijing Municipality, 100089

Other trials in China

About this study

Official title: 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

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.

IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.

Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan.

The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide.

Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints:

The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks.

The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights).

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Conditions: Diabetes Mellitus, Type 2
Being tested: IcoSema, insulin icodec, semaglutide
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IcoSemaDrug
One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
insulin icodecDrug
One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
semaglutideDrug
One single dose of semaglutide administered subcutaneously, S.c. into the left thigh

Study groups in NCT05435677
Study group	Role	What they receive
Sequence 1	Experimental	All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide
Sequence 2	Experimental	All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide
Sequence 3	Experimental	All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide
Sequence 4	Experimental	All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide
Sequence 5	Experimental	All participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide
Sequence 6	Experimental	All participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. Receives: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours*pmol/L
Measured: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Measured in (hours*nmol/L)/mg
Measured: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

Secondary outcomes (9)

AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours*pmol/L
Measured: From 0 hours to infinity after IMP administration (day 1)
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose
Measured in pmol/L
Measured: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose
Measured in hours
Measured: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Ico: Terminal half-life for insulin icodec after a single dose
Measured in hours
Measured: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Measured in (hours*nmol/L)/mg
Measured: From 0 hours to infinity after IMP administration (day 1)
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose
Measured in (nmol/L)/mg
Measured: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose
Measured in hours
Measured: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Sema: Terminal half-life for semaglutide after a single dose
Measured in hours
Measured: Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Adverse events
Number of events
Measured: From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202225 Apr 2023

First posted28 Jun 2022
Study start22 Jun 2022
Primary completion25 Apr 2023
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05435677
Sponsor's protocol ID: NN1535-4710
Other IDs: U1111-1262-1959
Status last verified: Mar 2025
First submitted: 23 Jun 2022
Last updated: 21 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Publications

Wang F, Luan Z, Maltesen R, Reenberg AT, Westergaard L, Liu D. Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. Diabetes Ther. 2025 Nov;16(11):2213-2225. doi: 10.1007/s13300-025-01803-x. Epub 2025 Oct 6.
PubMed 41051695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05435677
Acronym / sponsor ID: NN1535-4710
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 22 Jun 2022 (actual)
Primary completion: 25 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 28 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.

IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.

The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide.

Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints:

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
Sequence 2	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
Sequence 3	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
Sequence 4	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
Sequence 5	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
Sequence 6	Experimental	Drug: IcoSema, Drug: insulin icodec, Drug: semaglutideAll participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Chinese male or female
Aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
Body weight greater than or equal to 50 kg

Key exclusion criteria (4 listed)

Known or suspected hypersensitivity to trial product(s) or related products
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IcoSemaOne single dose of IcoSema administered subcutaneously, S.c. into the left thigh	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
insulin icodecOne single dose of insulin icodec administered subcutaneously, S.c. into the left thigh	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
semaglutideOne single dose of semaglutide administered subcutaneously, S.c. into the left thigh	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose
Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Measured in hours*pmol/L
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Measured in (hours*nmol/L)/mg

9 secondary outcomes

AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose
Time frame: From 0 hours to infinity after IMP administration (day 1)
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Ico: Terminal half-life for insulin icodec after a single dose
Time frame: Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Time frame: From 0 hours to infinity after IMP administration (day 1)
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose
Time frame: From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Sema: Terminal half-life for semaglutide after a single dose
Time frame: Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Adverse events
Time frame: From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Derived from this study: PubMed 41051695Wang F, Luan Z, Maltesen R, Reenberg AT, Westergaard L, Liu D. Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. Diabetes Ther. 2025 Nov;16(11):2213-2225. doi: 10.1007/s13300-025-01803-x. Epub 2025 Oct 6.
Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Transparency (dept. 2834) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IcoSema, insulin icodec and semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose (time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435677, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.