DiabetesPhase 1NCT02479022
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
A Phase 1 study testing Insulin 320 and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- Insulin 320 and insulin glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Dec 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as signed informed consent
- Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
- Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- Insulin 320, insulin glargine, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin 320Drug
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
insulin glargineDrug
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
placeboDrug
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Level 1-7 escalating doses | Experimental | Not described Receives: Drug: Insulin 320; Drug: insulin glargine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Measured: From the time of trial product administration and until 12 days after trial product administration
Secondary outcomes (2)
Area under the serum insulin concentration-time curve
Measured: From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve
Measured: From 0 to 24 hours after a single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479022
- Sponsor's protocol ID
- NN1957-4195
- Other IDs
- 2014-003918-92, U1111-1161-6716, 2014
- Status last verified
- Jul 2016
- First submitted
- 19 Jun 2015
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. 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 Insulin 320 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02479022
- Acronym / sponsor ID
- NN1957-4195
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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 trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Level 1-7 escalating doses | Experimental | Drug: Insulin 320, Drug: insulin glargine, Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as signed informed consent
- Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
- Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
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 |
|---|---|---|
| Insulin 320Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation. | Drug | Level 1-7 escalating doses |
| insulin glargineAs an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels. | Drug | Level 1-7 escalating doses |
| placeboSubjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels. | Drug | Level 1-7 escalating doses |
Primary outcome
Number of treatment-emergent adverse events
Time frame: From the time of trial product administration and until 12 days after trial product administration
2 secondary outcomes
Area under the serum insulin concentration-time curve
Time frame: From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve
Time frame: From 0 to 24 hours after a single dose
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 1 Aug 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 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 Insulin 320 and insulin glargine in people with Diabetes and 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 3 inclusion and 4 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 1 Aug 2016. 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 (time frame: From the time of trial product administration and until 12 days after trial product administration). 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 1 Aug 2016.