Diabetes Mellitus, Type 1Phase 1NCT05184868
AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
A Phase 1 study testing AT247, NovoLog and Fiasp in people with Diabetes Mellitus, Type 1, run by Arecor Limited at 1 site in United States.
Trial summary
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- AT247, NovoLog and Fiasp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 9 Sep 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with T1DM for at least 12 months.
- Subjects who have been using an approved insulin pump or use multiple daily injections with basal and bolus insulin, with a stable total insulin dose <1.2 U/kg/day and bolus insulin dose <0.7 U/kg/day for at least 3 months.
- Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.
- HbA1c concentration of ≤8.5% (≤69 mmol/mol).
- BMI within the range ≥18.5 - ≤28.0 kg/m2.
Who cannot join
- Known or suspected hypersensitivity to IMP or related products.
- History or presence of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
- Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
- Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg.
- Smoking more than 5 cigarettes per day or equivalent use of any tobacco containing product, and unable to refrain from smoking during the in-house periods of the study. A positive urine cotinine test at screening and check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- AT247, NovoLog, Fiasp
- 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.
AT247Drug
Ultra rapid acting prandial insulin aspart
NovoLogDrug
Also called NovoRapid
Rapid acting prandial insulin aspart
FiaspDrug
Fast acting prandial insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| AT247 | Experimental | 0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period Receives: Drug: AT247; Drug: NovoLog; Drug: Fiasp |
| NovoLog® | Active comparator | 0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period Receives: Drug: AT247; Drug: NovoLog; Drug: Fiasp |
| Fiasp® | Active comparator | 0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period Receives: Drug: AT247; Drug: NovoLog; Drug: Fiasp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under Curve for serum insulin
Measured: 0-30 minutes
Area under Curve for Glucose Infusion Rate
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 posted11 Jan 2022
- Study start3 Jan 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 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
- NCT05184868
- Sponsor's protocol ID
- ARE-247-103
- Status last verified
- Sep 2022
- First submitted
- 22 Dec 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII
- ClinicalTrials.gov ID
- NCT05184868
- Acronym / sponsor ID
- ARE-247-103
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arecor LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 11 Jan 2022 (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.
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)
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 | Drug: AT247, Drug: NovoLog, Drug: Fiasp0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period |
| NovoLog® | Active comparator | Drug: AT247, Drug: NovoLog, Drug: Fiasp0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period |
| Fiasp® | Active comparator | Drug: AT247, Drug: NovoLog, Drug: Fiasp0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects diagnosed with T1DM for at least 12 months.
- Subjects who have been using an approved insulin pump or use multiple daily injections with basal and bolus insulin, with a stable total insulin dose <1.2 U/kg/day and bolus insulin dose <0.7 U/kg/day for at least 3 months.
- Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.
- HbA1c concentration of ≤8.5% (≤69 mmol/mol).
- BMI within the range ≥18.5 - ≤28.0 kg/m2.
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity to IMP or related products.
- History or presence of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
- Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
- Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg.
- Smoking more than 5 cigarettes per day or equivalent use of any tobacco containing product, and unable to refrain from smoking during the in-house periods of the study. A positive urine cotinine test at screening and check-in.
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 |
|---|---|---|
| AT247Ultra rapid acting prandial insulin aspart | Drug | AT247, Fiasp®, NovoLog® |
| NovoLogAlso: NovoRapidRapid acting prandial insulin aspart | Drug | AT247, Fiasp®, NovoLog® |
| FiaspFast acting prandial insulin aspart | Drug | AT247, Fiasp®, NovoLog® |
Primary outcome
Area under Curve for serum insulin
Time frame: 0-30 minutes
Area under Curve for Glucose Infusion Rate
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 13 Sep 2022.
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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 AT247, NovoLog and Fiasp in people with Diabetes Mellitus, Type 1, run by Arecor Limited at 1 site in United States.
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 5 inclusion and 5 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 13 Sep 2022. 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 United States. 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 Curve for serum insulin (time frame: 0-30 minutes). The study lists 2 primary outcomes in all. 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 13 Sep 2022.