DiabetesPhase 1NCT02933853
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study testing Faster-acting insulin aspart and Insulin Aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- 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
- 61 participants
- Where
- 1 siteAustria
- Study dates
- 14 Oct 2016to 21 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
- Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
- HbA1C below or equal to 9.5 % based on central laboratory analysis
Who cannot join
- Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Faster-acting insulin aspart, Insulin Aspart
- 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.
Faster-acting insulin aspartDrug
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Insulin AspartDrug
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| Faster Aspart | 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 30 minutes
Secondary outcomes (3)
Maximum observed serum insulin aspart concentration
Measured: Within 0 to 12 hours after dosing
Area under the glucose infusion rate curve
Measured: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)
Maximum glucose infusion rate
Measured: Within 0 to 12 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start14 Oct 2016
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 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
- NCT02933853
- Sponsor's protocol ID
- NN1218-4265
- Other IDs
- 2016-000200-28, U1111-1178-3964, 2016
- Status last verified
- May 2019
- First submitted
- 13 Oct 2016
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10.
PubMed 31069935
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02933853
- Acronym / sponsor ID
- NN1218-4265
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 14 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.
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faster Aspart | Experimental | Drug: Faster-acting insulin aspart |
| Insulin Aspart | Active comparator | Drug: Insulin Aspart |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
- Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
- HbA1C below or equal to 9.5 % based on central laboratory analysis
Key exclusion criteria (2 listed)
- Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening
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 aspartA single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight. | Drug | Faster Aspart |
| Insulin AspartA single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight. | Drug | Insulin Aspart |
Primary outcome
Area under the serum insulin aspart concentration-time curve
Time frame: From 0 to 30 minutes
3 secondary outcomes
Maximum observed serum insulin aspart concentration
Time frame: Within 0 to 12 hours after dosing
Area under the glucose infusion rate curve
Time frame: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)
Maximum glucose infusion rate
Time frame: Within 0 to 12 hours after dosing
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 24 May 2019.
- Results publication: PubMed 31069935Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10.
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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 2, 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 2 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 24 May 2019. 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?
Area under the serum insulin aspart concentration-time curve (time frame: From 0 to 30 minutes). 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 NCT02933853, 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 24 May 2019.