DiabetesPhase 1NCT01469143
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
A Phase 1 study testing Faster-acting insulin aspart and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Faster-acting insulin aspart and insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jan 2012
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
- Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)
Who cannot join
- Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- Faster-acting insulin aspart, 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.
Faster-acting insulin aspartDrug
Also called NN1218
Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
insulin aspartDrug
At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
| Study group | Role | What they receive |
|---|---|---|
| NN1218 | Experimental | Not described Receives: Drug: Faster-acting 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.
Area under the serum insulin aspart concentration-time curve
Measured: From 0 to 1 hour
Secondary outcomes (3)
Area under the serum insulin aspart concentration-time curve
Measured: From 0 to 12 hours
Maximum observed serum insulin aspart concentration
Measured: From 0 to 12 hours
Time to maximum observed serum insulin aspart concentration
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 posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
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
- 40 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
- NCT01469143
- Sponsor's protocol ID
- NN1218-3977
- Other IDs
- 2011-004081-15, U1111-1123-6692
- Status last verified
- Feb 2015
- First submitted
- 8 Nov 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01469143
- Acronym / sponsor ID
- NN1218-3977
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Nov 2011 (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 purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NN1218 | Experimental | Drug: Faster-acting insulin aspart |
| insulin aspart | Active comparator | Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
- Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)
Key exclusion criteria (3 listed)
- Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches 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 aspartAlso: NN1218Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin). | Drug | NN1218 |
| insulin aspartAt one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin). | Drug | insulin aspart |
Primary outcome
Area under the serum insulin aspart concentration-time curve
Time frame: From 0 to 1 hour
3 secondary outcomes
Area under the serum insulin aspart concentration-time curve
Time frame: From 0 to 12 hours
Maximum observed serum insulin aspart concentration
Time frame: From 0 to 12 hours
Time to maximum observed serum insulin aspart concentration
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 23 Feb 2015.
- 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 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, 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 23 Feb 2015. 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 (time frame: From 0 to 1 hour). 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 23 Feb 2015.