DiabetesPhase 1NCT02089451
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects
A Phase 1 study testing Faster-acting insulin aspart in people with Diabetes and Healthy, 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 compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- What is being tested?
- Faster-acting insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 17 Mar 2014to 6 Jun 2014
- 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
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
Who cannot join
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.
- Being tested
- Faster-acting insulin aspart
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster-acting insulin aspartDrug
Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)
| Study group | Role | What they receive |
|---|---|---|
| FIAsp | Experimental | Each subject will be randomised to a treatment sequence consisting of 5 treatment periods Receives: Drug: Faster-acting insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)
Measured: From 0 to 12 hours
Secondary outcomes (2)
Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)
Measured: From 0 to 12 hours
Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)
Measured: From 0 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start17 Mar 2014
- Primary completion6 Jun 2014
- Study completion6 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 21 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
- NCT02089451
- Sponsor's protocol ID
- NN1218-3949
- Other IDs
- 2011-002590-32, U1111-1121-8351
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2014
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y.
PubMed 28185141
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02089451
- Acronym / sponsor ID
- NN1218-3949
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 6 Jun 2014 (actual)
- Study completion
- 6 Jun 2014 (actual)
- First posted
- 17 Mar 2014 (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 compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIAsp | Experimental | Drug: Faster-acting insulin aspartEach subject will be randomised to a treatment sequence consisting of 5 treatment periods |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-64 years both inclusive at the time of signing informed consent
- Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
- Body mass index 20.0-28.0 kg/m^2 (both inclusive)
Key exclusion criteria (3 listed)
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient 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 |
|---|---|---|
| Faster-acting insulin aspartDrug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein) | Drug | FIAsp |
Primary outcome
Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)
Time frame: From 0 to 12 hours
2 secondary outcomes
Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)
Time frame: From 0 to 12 hours
Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)
Time frame: From 0 to 12 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 17 Feb 2017.
- Results publication: PubMed 28185141Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y.
- 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 Faster-acting insulin aspart in people with Diabetes and Healthy, 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 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 17 Feb 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 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?
Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration) (time frame: From 0 to 12 hours). 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 NCT02089451, which also lists 1 linked publication.
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 17 Feb 2017.