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AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

Sponsor
Arecor Limited (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05184868
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
9.9
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 3, 2022
Actual Primary Completion Date :
Jul 29, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AT247

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

Drug: AT247
Ultra rapid acting prandial insulin aspart

Drug: NovoLog
Rapid acting prandial insulin aspart
Other Names:
  • NovoRapid

    • Drug: Fiasp
    Fast acting prandial insulin aspart
    Active Comparator: NovoLog®

    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

    Drug: AT247
    Ultra rapid acting prandial insulin aspart

    Drug: NovoLog
    Rapid acting prandial insulin aspart
    Other Names:
  • NovoRapid

    • Drug: Fiasp
    Fast acting prandial insulin aspart
    Active Comparator: Fiasp®

    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

    Drug: AT247
    Ultra rapid acting prandial insulin aspart

    Drug: NovoLog
    Rapid acting prandial insulin aspart
    Other Names:
  • NovoRapid

    • Drug: Fiasp
    Fast acting prandial insulin aspart

    Outcome Measures

    Primary Outcome Measures

    1. Area under Curve for serum insulin [0-30 minutes]

    2. Area under Curve for Glucose Infusion Rate [0-60 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subjects diagnosed with T1DM for at least 12 months.

    2. 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.

    3. Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.

    4. HbA1c concentration of ≤8.5% (≤69 mmol/mol).

    5. BMI within the range ≥18.5 - ≤28.0 kg/m2.

    Exclusion Criteria:

    1. Known or suspected hypersensitivity to IMP or related products.

    2. 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.

    3. Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.

    4. 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.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ProSciento, Inc Chula Vista California United States 91911

    Sponsors and Collaborators

    • Arecor Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arecor Limited
    ClinicalTrials.gov Identifier:
    NCT05184868
    Other Study ID Numbers:
    • ARE-247-103
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1
    Insulin Aspart

    Study Results

    No Results Posted as of Aug 15, 2022