Diabetes Mellitus, Type 2Phase 1NCT03617081
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
A Phase 1 study testing NNC0113-2023 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0113-2023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2018to 13 Dec 2018
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- 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.
Who cannot join
- HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Presence or history of pancreatitis (acute or chronic).
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0113-2023, Placebo (NNC0113-2023)
- 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.
NNC0113-2023Drug
Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.
Placebo (NNC0113-2023)Drug
Participants will receive NNC0174-0833 matched placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| NNC0113-2023 | Experimental | Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose. Receives: Drug: NNC0113-2023 |
| Placebo | Placebo comparator | Participants will receive placebo (NNC0113-2023) Receives: Drug: Placebo (NNC0113-2023) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count of events
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Secondary outcomes (4)
AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023
Measured in nmol/L*h
Measured: From baseline (day 1) to post treatment follow-up (day 43)
Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023
Measured in nmol/L
Measured: From baseline (day 1) to post treatment follow-up (day 43)
AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023
Measured in ng/mL*h
Measured: From baseline (day 1) to 24 hours after dosing
Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023
Measured in ng/mL
Measured: From baseline (day 1) to 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start9 Aug 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617081
- Sponsor's protocol ID
- NN9023-4408
- Other IDs
- U1111-1209-3837
- Status last verified
- Jan 2020
- First submitted
- 1 Aug 2018
- Last updated
- 10 Jan 2020
- 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 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03617081
- Acronym / sponsor ID
- NN9023-4408
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 6 Aug 2018 (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 aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0113-2023 | Experimental | Drug: NNC0113-2023Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose. |
| Placebo | Placebo comparator | Drug: Placebo (NNC0113-2023)Participants will receive placebo (NNC0113-2023) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- 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.
Key exclusion criteria (6 listed)
- HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
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 |
|---|---|---|
| NNC0113-2023Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose. | Drug | NNC0113-2023 |
| Placebo (NNC0113-2023)Participants will receive NNC0174-0833 matched placebo orally. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Count of events
4 secondary outcomes
AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023
Time frame: From baseline (day 1) to post treatment follow-up (day 43)
Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023
Time frame: From baseline (day 1) to post treatment follow-up (day 43)
AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023
Time frame: From baseline (day 1) to 24 hours after dosing
Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023
Time frame: From baseline (day 1) to 24 hours after dosing
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 10 Jan 2020.
- 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 Reporting Anchor and Disclosure (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 NNC0113-2023 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site 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 3 inclusion and 6 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 10 Jan 2020. 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 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. Some participants in this study may receive a placebo. 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 (TEAEs) (time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)). 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 10 Jan 2020.