Diabetes Mellitus, Type 1Phase 1NCT03965013
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
A Phase 1 study testing NNC0268-0965 and insulin glargine in people with Diabetes Mellitus, Type 1 and Healthy Volunteers, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Healthy Volunteers
- What is being tested?
- NNC0268-0965 and insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2019to 14 Dec 2019
- 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):
- 1. Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Part 2 (subjects with type 1 diabetes mellitus):
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
- Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilized (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause).
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- Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- HbA1c equal to or below 8.5%.
- Fasting C-peptide below 0.30 nmol/L.
Who cannot join
- (Part 1 and Part 2) 1. Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (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 NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.
- Conditions
- Diabetes Mellitus, Type 1, Healthy Volunteers
- Being tested
- NNC0268-0965, Placebo, insulin glargine
- 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.
NNC0268-0965Drug
2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
PlaceboDrug
A single dose of placebo given in Part 1
insulin glargineDrug
Insulin glargine given at a fixed dose level of 0.5 U/kg
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (healthy): NNC0268-0965 | Experimental | A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin) Receives: Drug: NNC0268-0965 |
| Part 1 (healthy): placebo | Placebo comparator | A single dose of placebo (NNC0268-0965) given s.c. Receives: Drug: Placebo |
| Part 2 (type 1 diabetes): NNC0268-0965 | Experimental | A single dose of NNC0268-0965 given s.c. Receives: Drug: NNC0268-0965 |
| Part 2 (type 1 diabetes): insulin glargine | Active comparator | A single dose of insulin glargine given s.c. Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Number of events
Measured: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Secondary outcomes (3)
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Measured: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Area under the serum NNC0268-0965 concentration-time curve after a single dose
pmol*h/L
Measured: From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum NNC0268-0965 concentration after a single dose
pmol/L
Measured: From 0 hours until last measurement time after trial product administration (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start5 Jun 2019
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
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
- Parallel groups
- Model description
- The study consists of 2 parts each with 2 arms. Part 1 is NNC0268-0965 vs. placebo in healthy volunteers. Part 2 is NNC0268-0965 vs. insulin glargine in subjects with type 1 diabetes mellitus.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 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
- NCT03965013
- Sponsor's protocol ID
- NN1965-4456
- Other IDs
- 2018-003922-98, U1111-1221-9696, 2018
- Status last verified
- Jan 2021
- First submitted
- 23 May 2019
- Last updated
- 14 Jan 2021
- 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 14 Jan 2021. 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 NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03965013
- Acronym / sponsor ID
- NN1965-4456
- Conditions
- Diabetes Mellitus, Type 1, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 28 May 2019 (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 medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study consists of 2 parts each with 2 arms. Part 1 is NNC0268-0965 vs. placebo in healthy volunteers. Part 2 is NNC0268-0965 vs. insulin glargine in subjects with type 1 diabetes mellitus.
| Arm | Type | Receives |
|---|---|---|
| Part 1 (healthy): NNC0268-0965 | Experimental | Drug: NNC0268-0965A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin) |
| Part 1 (healthy): placebo | Placebo comparator | Drug: PlaceboA single dose of placebo (NNC0268-0965) given s.c. |
| Part 2 (type 1 diabetes): NNC0268-0965 | Experimental | Drug: NNC0268-0965A single dose of NNC0268-0965 given s.c. |
| Part 2 (type 1 diabetes): insulin glargine | Active comparator | Drug: insulin glargineA single dose of insulin glargine given s.c. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Part 1 (healthy subjects):
- 1. Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Part 2 (subjects with type 1 diabetes mellitus):
Key exclusion criteria (1 listed)
- (Part 1 and Part 2) 1. Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (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 |
|---|---|---|
| NNC0268-09652 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2 | Drug | Part 1 (healthy): NNC0268-0965, Part 2 (type 1 diabetes): NNC0268-0965 |
| PlaceboA single dose of placebo given in Part 1 | Drug | Part 1 (healthy): placebo |
| insulin glargineInsulin glargine given at a fixed dose level of 0.5 U/kg | Drug | Part 2 (type 1 diabetes): insulin glargine |
Primary outcome
Number of treatment-emergent adverse events
Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Number of events
3 secondary outcomes
Number of treatment-emergent hypoglycaemic episodes
Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Area under the serum NNC0268-0965 concentration-time curve after a single dose
Time frame: From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum NNC0268-0965 concentration after a single dose
Time frame: From 0 hours until last measurement time after trial product administration (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 14 Jan 2021.
- 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 NNC0268-0965 and insulin glargine in people with Diabetes Mellitus, Type 1 and Healthy Volunteers, 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 9 inclusion and 1 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 14 Jan 2021. 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. 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 (time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10). 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 14 Jan 2021.