Diabetes Mellitus, Type 2Phase 1NCT04136067
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
A Phase 1 study testing NNC0268-0965 and insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0268-0965 and insulin glargine
- 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
- 29 Oct 2019to 23 Aug 2020
- 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, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
- Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (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) prior to the day of screening.
- Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- HbA1c equal to or below 9.5%
Who cannot join
- 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%).
- Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.
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 Subjects With Type 2 Diabetes Mellitus
This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 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. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0268-0965, insulin glargine
- 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.
NNC0268-0965Drug
One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days
insulin glargineDrug
One daily dose of 3.0 nmol/kg administered s.c. for 6 days
| Study group | Role | What they receive |
|---|---|---|
| NNC0268-0965 | Experimental | Participants will receive NNC0268-0965 Receives: Drug: NNC0268-0965 |
| Insulin glargine | Active comparator | Participants will receive insulin glargine 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 (AEs)
Number of events
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Secondary outcomes (3)
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state
pmol*h/l
Measured: From 0 to 24 hours after IMP administration at day 6 (visit 2)
Maximum observed serum NNC0268-0965 concentration after the last dose
pmol/l
Measured: From 0 to 24 hours after IMP administration at day 6 (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start29 Oct 2019
- Primary completion23 Aug 2020
- Study completion23 Aug 2020
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
- Model description
- 3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT04136067
- Sponsor's protocol ID
- NN1965-4457
- Other IDs
- U1111-1227-8683, 2019-000754-58, 2019
- Status last verified
- Sep 2022
- First submitted
- 21 Oct 2019
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. 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 Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04136067
- Acronym / sponsor ID
- NN1965-4457
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 23 Aug 2020 (actual)
- Study completion
- 23 Aug 2020 (actual)
- First posted
- 23 Oct 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 looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 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. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.
| Arm | Type | Receives |
|---|---|---|
| NNC0268-0965 | Experimental | Drug: NNC0268-0965Participants will receive NNC0268-0965 |
| Insulin glargine | Active comparator | Drug: insulin glargineParticipants will receive insulin glargine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
- Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (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) prior to the day of screening.
- Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- HbA1c equal to or below 9.5%
Key exclusion criteria (2 listed)
- 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%).
- Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.
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 |
|---|---|---|
| NNC0268-0965One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days | Drug | NNC0268-0965 |
| insulin glargineOne daily dose of 3.0 nmol/kg administered s.c. for 6 days | Drug | Insulin glargine |
Primary outcome
Number of treatment-emergent adverse events (AEs)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Number of events
3 secondary outcomes
Number of treatment-emergent hypoglycaemic episodes
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state
Time frame: From 0 to 24 hours after IMP administration at day 6 (visit 2)
Maximum observed serum NNC0268-0965 concentration after the last dose
Time frame: From 0 to 24 hours after IMP administration at day 6 (visit 2)
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 8 Sep 2022.
- 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 2, 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 5 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 8 Sep 2022. 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: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)). 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 8 Sep 2022.