Diabetes Mellitus, Type 1Phase 1NCT03959514
AT247, NovoRapid® and Fiasp® in Glucose Clamp Study
A Phase 1 study testing NovoRapid, Fiasp and AT247 in people with Diabetes Mellitus, Type 1, run by Arecor Limited at 1 site in Austria.
Trial summary
A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- NovoRapid, Fiasp and AT247
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 12 Apr 2019to 8 Aug 2019
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis type I Diabetes Mellitus for at least 12 months
- Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
- Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
- BMI 18.5-35.0 kg/m2
Who cannot join
- known or suspected hypersensitivity to Investigational Medicinal Products
- clinically significant concomitant disease or abnormal lab values
- supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).
A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- NovoRapid, Fiasp, AT247
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoRapidBiological
Also called NovoLog
Rapid acting prandial insulin aspart
FiaspBiological
Fast acting prandial insulin aspart
AT247Biological
Ultra rapid acting prandial insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| AT247 | Experimental | Single subcutaneous injection 0.3 U/Kg Receives: Biological: NovoRapid; Biological: Fiasp; Biological: AT247 |
| NovoRapid | Active comparator | Single subcutaneous injection 0.3 U/Kg Receives: Biological: NovoRapid; Biological: Fiasp; Biological: AT247 |
| Fiasp | Active comparator | Single subcutaneous injection 0.3 U/Kg Receives: Biological: NovoRapid; Biological: Fiasp; Biological: AT247 |
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: 0-60 minutes
Secondary outcomes (1)
Area under the serum insulin aspart concentration-time curve from 0-60 minutes
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start12 Apr 2019
- Primary completion30 Jul 2019
- Study completion8 Aug 2019
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 1Studies 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
- 18 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
- NCT03959514
- Sponsor's protocol ID
- ARE-247-101
- Status last verified
- Sep 2019
- First submitted
- 13 May 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svehlikova E, Mursic I, Augustin T, Magnes C, Gerring D, Jezek J, Schwarzenbacher D, Ratzer M, Wolf M, Howell S, Zakrzewski L, Urschitz M, Tschapeller B, Gatschelhofer C, Feichtner F, Lawrence F, Pieber TR. Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double-Blind, Crossover Study in Men With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):448-455. doi: 10.2337/dc20-1017. Epub 2020 Dec 16.
PubMed 33328285
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).
- ClinicalTrials.gov ID
- NCT03959514
- Acronym / sponsor ID
- ARE-247-101
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arecor LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 22 May 2019 (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.
A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AT247 | Experimental | Biological: NovoRapid, Biological: Fiasp, Biological: AT247Single subcutaneous injection 0.3 U/Kg |
| NovoRapid | Active comparator | Biological: NovoRapid, Biological: Fiasp, Biological: AT247Single subcutaneous injection 0.3 U/Kg |
| Fiasp | Active comparator | Biological: NovoRapid, Biological: Fiasp, Biological: AT247Single subcutaneous injection 0.3 U/Kg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis type I Diabetes Mellitus for at least 12 months
- Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
- Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
- BMI 18.5-35.0 kg/m2
Key exclusion criteria (3 listed)
- known or suspected hypersensitivity to Investigational Medicinal Products
- clinically significant concomitant disease or abnormal lab values
- supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
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 |
|---|---|---|
| NovoRapidAlso: NovoLogRapid acting prandial insulin aspart | Biological | AT247, Fiasp, NovoRapid |
| FiaspFast acting prandial insulin aspart | Biological | AT247, Fiasp, NovoRapid |
| AT247Ultra rapid acting prandial insulin aspart | Biological | AT247, Fiasp, NovoRapid |
Primary outcome
Area under the glucose infusion rate-time curve of insulin aspart
Time frame: 0-60 minutes
1 secondary outcome
Area under the serum insulin aspart concentration-time curve from 0-60 minutes
Time frame: 0-60 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 30 Sep 2019.
- Derived from this study: PubMed 33328285Svehlikova E, Mursic I, Augustin T, Magnes C, Gerring D, Jezek J, Schwarzenbacher D, Ratzer M, Wolf M, Howell S, Zakrzewski L, Urschitz M, Tschapeller B, Gatschelhofer C, Feichtner F, Lawrence F, Pieber TR. Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double-Blind, Crossover Study in Men With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):448-455. doi: 10.2337/dc20-1017. Epub 2020 Dec 16.
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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 NovoRapid, Fiasp and AT247 in people with Diabetes Mellitus, Type 1, 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 4 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 30 Sep 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 glucose infusion rate-time curve of insulin aspart (time frame: 0-60 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 NCT03959514, 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 30 Sep 2019.