DiabetesPhase 1NCT02938572
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
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 this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- NNC0143-0406 and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteAustria
- Study dates
- 19 Oct 2016to 4 Jul 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female 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
- Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening
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 ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus
- 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
Administered subcutaneously (s.c. under the skin)
Insulin AspartDrug
Administered subcutaneously (s.c. under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC0143-0406 | Experimental | Not described Receives: Drug: NNC0143-0406 |
| 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 ratio of suppression of endogenous glucose production relative to total glucose lowering effect
Measured: Two weeks of treatment
Secondary outcomes (1)
Number of treatment emergent adverse events
Measured: Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start19 Oct 2016
- Primary completion17 Jun 2017
- Study completion4 Jul 2017
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938572
- Sponsor's protocol ID
- NN1406-4218
- Other IDs
- 2014-005340-18, U1111-1164-6715, 2014
- Status last verified
- Feb 2018
- First submitted
- 17 Oct 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02938572
- Acronym / sponsor ID
- NN1406-4218
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 17 Jun 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 19 Oct 2016 (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 this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0143-0406 | Experimental | Drug: NNC0143-0406 |
| Insulin aspart | Active comparator | Drug: Insulin Aspart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female 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
- Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening
Key exclusion criteria (3 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 ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)
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 |
|---|---|---|
| NNC0143-0406Administered subcutaneously (s.c. under the skin) | Drug | NNC0143-0406 |
| Insulin AspartAdministered subcutaneously (s.c. under the skin) | Drug | Insulin aspart |
Primary outcome
The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
Time frame: Two weeks of treatment
1 secondary outcome
Number of treatment emergent adverse events
Time frame: Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration
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 26 Feb 2018.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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) 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 3 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 26 Feb 2018. 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 ratio of suppression of endogenous glucose production relative to total glucose lowering effect (time frame: Two weeks of treatment). 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 26 Feb 2018.