Diabetes Mellitus, Type 1Phase 1NCT07305805
A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes
A Phase 1 study testing NNC0363-1063 in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- NNC0363-1063
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 16 Dec 2025to 8 May 2026
- 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
- Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive) at the day of screening.
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.
- Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.
Who cannot join
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes
The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- NNC0363-1063
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0363-1063Drug
NNC0363-1063 will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. Receives: Drug: NNC0363-1063 |
| Sequence 2 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. Receives: Drug: NNC0363-1063 |
| Sequence 3 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. Receives: Drug: NNC0363-1063 |
| Sequence 4 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. Receives: Drug: NNC0363-1063 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
Measured in milligrams per kilogram (mg/kg).
Measured: Visit 2 and 3: Day 2 and 3
Secondary outcomes (6)
GIRmax,SS: Maximum glucose infusion rate at steady state
Measured in milligrams per kilogram*minute (mg/[kg*min]).
Measured: Visit 2 and 3: Day 2 and 3
Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state
Measured in hours.
Measured: Visit 2 and 3: Day 2 and 3
AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state
Measured in hours*picomoles per litre (h*pmol/L).
Measured: Visit 2 and 3: Day 2 and 3
Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state
Measured in picomoles per litre (pmol/L).
Measured: Visit 2 and 3: Day 2 and 3
tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state
Measured in hours.
Measured: Visit 2 and 3: Day 2 and 3
Number of adverse events
Measured as number of events.
Measured: Visit 2 and 3: Day 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start16 Dec 2025
- Primary completion21 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- None (open label)
- Enrolment
- 36 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
- NCT07305805
- Sponsor's protocol ID
- NN1644-8194
- Other IDs
- U1111-1317-2815, 2025-521593-33, 2025
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2025
- Last updated
- 5 Jun 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07305805
- Acronym / sponsor ID
- NN1644-8194
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 26 Dec 2025 (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.
The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 2 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 3 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 4 | Experimental | Drug: NNC0363-1063Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive) at the day of screening.
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.
Key exclusion criteria (2 listed)
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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 |
|---|---|---|
| NNC0363-1063NNC0363-1063 will be administered subcutaneously. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
Time frame: Visit 2 and 3: Day 2 and 3
Measured in milligrams per kilogram (mg/kg).
6 secondary outcomes
GIRmax,SS: Maximum glucose infusion rate at steady state
Time frame: Visit 2 and 3: Day 2 and 3
Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state
Time frame: Visit 2 and 3: Day 2 and 3
AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state
Time frame: Visit 2 and 3: Day 2 and 3
Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state
Time frame: Visit 2 and 3: Day 2 and 3
tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state
Time frame: Visit 2 and 3: Day 2 and 3
Number of adverse events
Time frame: Visit 2 and 3: Day 2 and 3
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 5 Jun 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
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 NNC0363-1063 in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
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 5 Jun 2026. 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 Germany. 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?
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state (time frame: Visit 2 and 3: Day 2 and 3). 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 5 Jun 2026.