Diabetes Mellitus, Type 2Phase 1NCT05790681
A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 21 sites in United States.
Trial summary
Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin icodec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 21 sitesUnited States
- Study dates
- 25 Apr 2023to 8 Feb 2024
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female
- Aged 10 to less than (<) 18 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 30 days prior to the day of screening
- Glycated haemoglobin (HbA1c) less than or equal to (<=) 10% (86 millimoles per mole [mmol/mol]) at screening
- Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s).
- Current daily basal insulin treatment >= 0.2 (I) units per kilogram per day (U/kg/day) with stable doses >=30 days prior to the day of screening
Who cannot join
- Known or suspected hypersensitivity to study interventions or related products
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Texas Tech University HSC
Amarillo, Texas, 79106
John Hopkins Univ Hosp
Baltimore, Maryland, 21287
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808
UBMD Pediatrics
Buffalo, New York, 14203
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203
University of Virginia Clinical Research Unit
Charlottesville, Virginia, 22908
University of Virginia
Charlottesville, Virginia, 22908
Childrens Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Child's Hsp Med Ctr
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
University Of Iowa_Iowa City
Iowa City, Iowa, 52242
University of Iowa
Iowa City, Iowa, 52242
Nemours Children's Health
Jacksonville, Florida, 32207
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, 32207
Children's Hosp-Los Angeles
Los Angeles, California, 90027
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027
Yale New Haven Hospital, Hospital Research Unit
New Haven, Connecticut, 06510
Yale University
New Haven, Connecticut, 06511
Children's Hosp Of Phil
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224
NE Clin Res of San Antonio
Schertz, Texas, 78154
About this study
Official title: A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes
Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. The study will last for about 8 weeks. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 milliliter (mL) (a little less than a quarter of a teaspoonful). The amount of insulin icodec participant will receive depends on participant's body weight. Participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin icodec
- 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.
Insulin icodecDrug
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing. Receives: Drug: Insulin icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
Measured in picomoles*hours per liter (pmol*h/L).
Measured: From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Measured in picomoles per liter (pmol/L).
Measured: From 0 hours until last measurement time after trial product administration (day 1)
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Measured in hours.
Measured: From 0 hours until last measurement time after trial product administration (day 1)
Secondary outcomes (2)
Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
Measured in pmol/L.
Measured: From 0 to 168 hours after trial product administration
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Measured in pmol*h/L.
Measured: From 0 to 168 hours after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start25 Apr 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790681
- Sponsor's protocol ID
- NN1436-4888
- Other IDs
- U1111-1271-9231
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2023
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Pharmacokinetic Properties of Insulin Icodec in Children and Adolescents With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05790681
- Acronym / sponsor ID
- NN1436-4888
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 30 Mar 2023 (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.
Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. The study will last for about 8 weeks. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 milliliter (mL) (a little less than a quarter of a teaspoonful). The amount of insulin icodec participant will receive depends on participant's body weight. Participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Drug: Insulin icodecParticipants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male or female
- Aged 10 to less than (<) 18 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 30 days prior to the day of screening
- Glycated haemoglobin (HbA1c) less than or equal to (<=) 10% (86 millimoles per mole [mmol/mol]) at screening
- Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s).
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to study interventions or related products
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
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 |
|---|---|---|
| Insulin icodecParticipants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight. | Drug | Participants with Type 2 Diabetes |
Primary outcome
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD)
Time frame: From 0 hours until infinity after trial product administration (day 1)
Measured in picomoles*hours per liter (pmol*h/L).
Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD)
Time frame: From 0 hours until last measurement time after trial product administration (day 1)
Measured in picomoles per liter (pmol/L).
Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD)
Time frame: From 0 hours until last measurement time after trial product administration (day 1)
Measured in hours.
2 secondary outcomes
Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model)
Time frame: From 0 to 168 hours after trial product administration
Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model)
Time frame: From 0 to 168 hours after trial product administration
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 9 Apr 2026.
- 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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 21 sites in United States.
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 6 inclusion and 2 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD) (time frame: From 0 hours until infinity after trial product administration (day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.