Healthy VolunteersPhase 1NCT04569994
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
A Phase 1 study testing NNC0363-0845 and Insulin degludec in people with Healthy Volunteers and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Diabetes Mellitus, Type 1
- What is being tested?
- NNC0363-0845 and Insulin degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2020to 23 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 1 (healthy subjects):
- Male subject or female subject 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 months without an alternative medical cause) prior to the day of screening.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Part 2 and 3 (subjects with type 1 diabetes mellitus):
- Male subject or female subject 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 months without an alternative medical cause) prior to the day of screening.
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- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus 1 year or more prior to the day of screening.
- Glycated haemoglobin (HbA1c) equal to or below 8.5%.
- Fasting C-peptide below 0.30 nmol/L.
- Considered to be generally healthy (except for type 1 diabetes mellitus and sequelae of diabetes which may only be of mild severity) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Part 1 (healthy subjects) Part 2 and Part 3 (subjects with type 1 diabetes mellitus):
- Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes
This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D.
The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours.
Read more
For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks.
Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 1
- Being tested
- NNC0363-0845, Placebo (NNC0363-0845), Insulin degludec
- 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.
NNC0363-0845Drug
A single dose administered s.c. (subcutaneously, under the skin)
Placebo (NNC0363-0845)Drug
A single dose administered s.c.
Insulin degludecDrug
A single dose administered s.c.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Healthy volunteers will receive either NNC0363-0845 or placebo Receives: Drug: NNC0363-0845; Drug: Placebo (NNC0363-0845) |
| Part 2 | Experimental | Participants with T1D will receive either NNC0363-0845 or insulin degludec Receives: Drug: NNC0363-0845; Drug: Insulin degludec |
| Part 3 | Experimental | Participants with T1D will receive NNC0363-0845 Receives: Drug: NNC0363-0845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (AEs)
Number of events
Measured: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent adverse events (AEs)
Number of events
Measured: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Secondary outcomes (6)
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Measured: Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Measured: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
pmol*h/L
Measured: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
pmol*h/L
Measured: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
pmol/L
Measured: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
pmol/L
Measured: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start30 Sep 2020
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Model description
- Part 1 will be a placebo-controlled trial in healthy subjects; Part 2 will be an active-controlled trial in subjects with T1D. Part 3 of this trial, will be an open-label, two-period cross-over, randomised, single dose trial in subjects with T1D.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency and Medical Writing Office (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569994
- Sponsor's protocol ID
- NN1845-4598
- Other IDs
- U1111-1244-4315, 2019-004658-27, 2019
- Status last verified
- Jun 2023
- First submitted
- 24 Sep 2020
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04569994
- Acronym / sponsor ID
- NN1845-4598
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 30 Sep 2020 (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 is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D.
The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours.
For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks.
Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part 1 will be a placebo-controlled trial in healthy subjects; Part 2 will be an active-controlled trial in subjects with T1D. Part 3 of this trial, will be an open-label, two-period cross-over, randomised, single dose trial in subjects with T1D.
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: NNC0363-0845, Drug: Placebo (NNC0363-0845)Healthy volunteers will receive either NNC0363-0845 or placebo |
| Part 2 | Experimental | Drug: NNC0363-0845, Drug: Insulin degludecParticipants with T1D will receive either NNC0363-0845 or insulin degludec |
| Part 3 | Experimental | Drug: NNC0363-0845Participants with T1D will receive NNC0363-0845 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male subject or female subject 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 months without an alternative medical cause) prior to the day of screening.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Male subject or female subject 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 months without an alternative medical cause) prior to the day of screening.
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
Key exclusion criteria (2 listed)
- Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
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 |
|---|---|---|
| NNC0363-0845A single dose administered s.c. (subcutaneously, under the skin) | Drug | Part 1, Part 2, Part 3 |
| Placebo (NNC0363-0845)A single dose administered s.c. | Drug | Part 1 |
| Insulin degludecA single dose administered s.c. | Drug | Part 2 |
Primary outcome
Number of treatment-emergent adverse events (AEs)
Time frame: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of events
Number of treatment-emergent adverse events (AEs)
Time frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Number of events
6 secondary outcomes
Number of treatment-emergent hypoglycaemic episodes
Time frame: Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent hypoglycaemic episodes
Time frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
Time frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
Time frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
Time frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
Time frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
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 27 Jun 2023.
- 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 and Medical Writing Office (1452) 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 NNC0363-0845 and Insulin degludec in people with Healthy Volunteers and 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 11 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 27 Jun 2023. 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?
Number of treatment-emergent adverse events (AEs) (time frame: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10). 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?
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 27 Jun 2023.