DiabetesPhase 1NCT02612844
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes
A Phase 1 study testing NNC0143-0406 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
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 subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- NNC0143-0406 and insulin aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2015to Jun 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive)
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral contraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Malesubjects must also agree to refrain from sperm donation from randomisation until 90 days after dosing
- History or presence of any clinically relevant respiratory, metabolic (including dyslipidaemia), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 90 days prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the last 180 days
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 subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- NNC0143-0406, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0143-0406Drug
Subject will receive one single dose only Subcutanesously (s.c., under the skin)
insulin aspartDrug
Subject will receive one single dose only. Subcutanesously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC0143-0406 | Experimental | Not described Receives: Drug: NNC0143-0406; Drug: insulin aspart |
| Insulin Aspart | Active comparator | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of treatment emergent adverse events
Measured: From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.
Secondary outcomes (3)
Area under the serum NNC0143-0406 concentration-time curve
Measured: From 0 to 24 hours
Area under the glucose infusion rate-time curve
Measured: From 0 to 24 hours
The maximum glucose infusion rate
Measured: From 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT02612844
- Sponsor's protocol ID
- NN1406-4209
- Other IDs
- 2014-005334-63, U1111-1164-6630, 2014
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2015
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. 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 NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02612844
- Acronym / sponsor ID
- NN1406-4209
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Nov 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 subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0143-0406 | Experimental | Drug: NNC0143-0406, Drug: insulin aspart |
| Insulin Aspart | Active comparator | Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive)
Key exclusion criteria (6 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral contraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Malesubjects must also agree to refrain from sperm donation from randomisation until 90 days after dosing
- History or presence of any clinically relevant respiratory, metabolic (including dyslipidaemia), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 90 days prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
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 |
|---|---|---|
| NNC0143-0406Subject will receive one single dose only Subcutanesously (s.c., under the skin) | Drug | NNC0143-0406 |
| insulin aspartSubject will receive one single dose only. Subcutanesously (s.c., under the skin) | Drug | Insulin Aspart, NNC0143-0406 |
Primary outcome
The number of treatment emergent adverse events
Time frame: From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.
3 secondary outcomes
Area under the serum NNC0143-0406 concentration-time curve
Time frame: From 0 to 24 hours
Area under the glucose infusion rate-time curve
Time frame: From 0 to 24 hours
The maximum glucose infusion rate
Time frame: From 0 to 24 hours
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 6 Dec 2017.
- 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 NNC0143-0406 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
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 6 Dec 2017. 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 Austria. 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?
The number of treatment emergent adverse events (time frame: From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.). 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 6 Dec 2017.