Healthy VolunteersPhase 1NCT04262661

A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes

A Phase 1 study testing NNC0472-0147 and insulin glargine in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Diabetes Mellitus, Type 2
What is being tested?: NNC0472-0147 and insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 2 sitesGermany
Study dates: 2 Mar 2020to 25 Sep 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
Healthy volunteers accepted
Adult

Who may be able to join

Part 1:
Male
Aged 18-55 years (both inclusive) at the time of signing nformed consent.
Part 2:
Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (no menses for 12 months without an alternative medical cause) prior to the day of screening.
Aged 18-64 years (both inclusive) at the time of signing informed consent.

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Diagnosed with T2DM at least 180 days prior to the day of screening.
Treated with any insulin for 90 days or longer prior to the day of screening.
Low-density lipoprotein cholesterol level above 1.80 mmol L.

Who cannot join

Part 1:
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Part 2:
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Use of oral antidiabetic drugs (OADs) other than metformin or use of glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 90 days prior to the day of screening.
Treatment with peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 180 days prior to the day of screening.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0472-0147 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

This study is investigating the safety and tolerability of the new medicine NNC0472-0147, its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. Another goal of the study is to determine an effect of NNC0472-0147 on cholesterol. The first part of the study is conducted in healthy people, while the second part involves people with type 2 diabetes (T2DM). The study will test how NNC0472-0147 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much blood sugar is lowered. In part 1, participants will either get the new medicine NNC0472-0147 or placebo (an injection that does not contain active medicine) - which treatment is decided by chance. In part 2, participants will either get the new medicine NNC0472-0147 or insulin glargine - which treatment is decided by chance. It is the first time that NNC0472-0147 is tested in humans. Participants will get once daily injections of either NNC0472-0147 or insulin glargine for a treatment period of fourteen days. The injections will be given under the skin (subcutaneously, s.c.) of the left thigh. Participants will be in the study for about 7 weeks. There will be 15 visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health. Only women who cannot become pregnant are allowed to participate.

Conditions: Healthy Volunteers, Diabetes Mellitus, Type 2
Being tested: NNC0472-0147, insulin glargine, Placebo (NNC0472-0147)
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.

NNC0472-0147Drug
Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.
insulin glargineDrug
Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.
Placebo (NNC0472-0147)Drug
Part 1: A single dose of placebo, dose increased in each cohort.

Study groups in NCT04262661
Study group	Role	What they receive
NNC0472-0147 Part 1	Experimental	Part 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147. Receives: Drug: NNC0472-0147
Placebo Part 1	Placebo comparator	Part 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo. Receives: Drug: Placebo (NNC0472-0147)
NNC0472-0147 Part 2	Experimental	Part 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days Receives: Drug: NNC0472-0147
Insulin glargine Part 2	Active comparator	Part 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days. Receives: Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Number of treatment emergent adverse events
Number of events
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Part 2: Number of treatment emergent adverse events
Number of events
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

Secondary outcomes (10)

Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Measured: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Area under the serum NNC0472-0147 concentration-time curve after a single dose
pmol*h/L
Measured: From 0 hours until infinity after a single IMP administration at day 1 (visit 2).
Maximum observed serum NNC0472-0147 concentration after a single dose
pmol/L
Measured: From 0 hours until last measurement time after a single IMP administration at day 1 (visit 2)
Area under the serum NNC0472-0147 concentration-time curve during one dosing interval at steady state
pmol*h/L
Measured: From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)
Maximum observed serum NNC0472-0147 concentration at steady state
pmol/L
Measured: From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202025 Sep 2020

First posted10 Feb 2020
Study start2 Mar 2020
Primary completion25 Sep 2020
Study completion25 Sep 2020

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: Parallel groups
Model description: Part 1: Single ascending dose, placebo control. Part 2: Multiple ascending dose design, active control.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04262661
Sponsor's protocol ID: NN1147-4527
Other IDs: U1111-1232-3957, 2019-001927-11, 2019
Status last verified: Sep 2022
First submitted: 7 Feb 2020
Last updated: 28 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 28 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 NNC0472-0147 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04262661
Acronym / sponsor ID: NN1147-4527
Conditions: Healthy Volunteers, 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: 2 Mar 2020 (actual)
Primary completion: 25 Sep 2020 (actual)
Study completion: 25 Sep 2020 (actual)
First posted: 10 Feb 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.

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: Part 1: Single ascending dose, placebo control. Part 2: Multiple ascending dose design, active control.

Arm	Type	Receives
NNC0472-0147 Part 1	Experimental	Drug: NNC0472-0147Part 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.
Placebo Part 1	Placebo comparator	Drug: Placebo (NNC0472-0147)Part 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.
NNC0472-0147 Part 2	Experimental	Drug: NNC0472-0147Part 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days
Insulin glargine Part 2	Active comparator	Drug: insulin glarginePart 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male
Aged 18-55 years (both inclusive) at the time of signing nformed consent.
Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (no menses for 12 months without an alternative medical cause) prior to the day of screening.
Aged 18-64 years (both inclusive) at the time of signing informed consent.
Diagnosed with T2DM at least 180 days prior to the day of screening.

Key exclusion criteria (6 listed)

Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Use of oral antidiabetic drugs (OADs) other than metformin or use of glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 90 days prior to the day of screening.
Treatment with peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 180 days prior to the day of 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
NNC0472-0147Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.	Drug	NNC0472-0147 Part 1, NNC0472-0147 Part 2
insulin glarginePart 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.	Drug	Insulin glargine Part 2
Placebo (NNC0472-0147)Part 1: A single dose of placebo, dose increased in each cohort.	Drug	Placebo Part 1

Primary outcome

Part 1: Number of treatment emergent adverse events
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of events
Part 2: Number of treatment emergent adverse events
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Number of events

10 secondary outcomes

Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Number of severe hypoglycaemic episodes (level 3)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of severe hypoglycaemic episodes (level 3)
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Area under the serum NNC0472-0147 concentration-time curve after a single dose
Time frame: From 0 hours until infinity after a single IMP administration at day 1 (visit 2).
Maximum observed serum NNC0472-0147 concentration after a single dose
Time frame: From 0 hours until last measurement time after a single IMP administration at day 1 (visit 2)
Area under the serum NNC0472-0147 concentration-time curve during one dosing interval at steady state
Time frame: From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)
Maximum observed serum NNC0472-0147 concentration at steady state
Time frame: From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)

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 28 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 & Disclosure (1452) study director

Novo Nordisk A/S

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0472-0147 and insulin glargine in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites 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 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 28 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 2 sites 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?

Part 1: Number of treatment emergent adverse events (time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)). 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?

On the ClinicalTrials.gov record for NCT04262661.

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 28 Sep 2022.