Diabetes Mellitus, Type 2Phase 1NCT05754424
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
A Phase 1 study testing AT278, NovoRapid and Humulin R 500 UNT/ML Injectable Solution in people with Diabetes Mellitus, Type 2, run by Arecor Limited at 1 site in Austria.
Trial summary
This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AT278, NovoRapid and Humulin R 500 UNT/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- 27 Feb 2023to 12 Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
- Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
- BMI within the range of 25 - 45 kg/m2 (both inclusive)
Who cannot join
- Known or suspected hypersensitivity to IMPs or related products
- Clinically significant concomitant disease or abnormal lab values
- Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.
This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- AT278, NovoRapid, Humulin R 500 UNT/ML Injectable Solution
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT278Drug
Concentrated rapid acting insulin aspart
NovoRapidDrug
Rapid-acting insulin aspart
Humulin R 500 UNT/ML Injectable SolutionDrug
Regular human insulin
| Study group | Role | What they receive |
|---|---|---|
| AT278 | Experimental | Single subcutaneous injection of 0.5 U/kg Receives: Drug: AT278; Drug: NovoRapid; Drug: Humulin R 500 UNT/ML Injectable Solution |
| NovoRapid | Active comparator | Single subcutaneous injection of 0.5 U/kg Receives: Drug: AT278; Drug: NovoRapid; Drug: Humulin R 500 UNT/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the glucose infusion rate-time curve of insulin aspart
Measured: 0 to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start27 Feb 2023
- Primary completion18 Jan 2024
- Study completion12 Feb 2024
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arecor Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754424
- Sponsor's protocol ID
- ARE-278-104
- Other IDs
- 2022-001984-28
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svehlikova E, Gatschelhofer C, Lackner B, Ratzer M, Fluhr G, Stoisser A, Kolaric G, Gerring D, Howell S, Jezek J, Lawrence F, Pieber TR. A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI. Diabetes Obes Metab. 2026 Jul 30. doi: 10.1111/dom.71150. Online ahead of print.
PubMed 42530378
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT05754424
- Acronym / sponsor ID
- ARE-278-104
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Arecor LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 3 Mar 2023 (actual)
- 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 is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT278 | Experimental | Drug: AT278, Drug: NovoRapid, Drug: Humulin R 500 UNT/ML Injectable SolutionSingle subcutaneous injection of 0.5 U/kg |
| NovoRapid | Active comparator | Drug: AT278, Drug: NovoRapid, Drug: Humulin R 500 UNT/ML Injectable SolutionSingle subcutaneous injection of 0.5 U/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
- Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
- BMI within the range of 25 - 45 kg/m2 (both inclusive)
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to IMPs or related products
- Clinically significant concomitant disease or abnormal lab values
- Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
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 |
|---|---|---|
| AT278Concentrated rapid acting insulin aspart | Drug | AT278, NovoRapid |
| NovoRapidRapid-acting insulin aspart | Drug | AT278, NovoRapid |
| Humulin R 500 UNT/ML Injectable SolutionRegular human insulin | Drug | AT278, NovoRapid |
Primary outcome
Area under the glucose infusion rate-time curve of insulin aspart
Time frame: 0 to 60 minutes
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 16 Feb 2024.
- Derived from this study: PubMed 42530378Svehlikova E, Gatschelhofer C, Lackner B, Ratzer M, Fluhr G, Stoisser A, Kolaric G, Gerring D, Howell S, Jezek J, Lawrence F, Pieber TR. A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI. Diabetes Obes Metab. 2026 Jul 30. doi: 10.1111/dom.71150. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AT278, NovoRapid and Humulin R 500 UNT/ML Injectable Solution in people with Diabetes Mellitus, Type 2, run by Arecor Limited 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 16 Feb 2024. 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 glucose infusion rate-time curve of insulin aspart (time frame: 0 to 60 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 NCT05754424, 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 16 Feb 2024.