Clincosm LogoSign in Get a demo

AT278 and NovoRapid® in Glucose Clamp Study

Sponsor
Arecor Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04660305
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
6.3
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
Jun 3, 2021
Actual Study Completion Date :
Jun 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: AT278

Single subcutaneous injection 0.3U/kg

Drug: AT278
Concentrated rapid acting insulin aspart

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

    		•
    Active Comparator: NovoRapid

    Single subcutaneous injection 0.3U/kg

    Drug: AT278
    Concentrated rapid acting insulin aspart

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the glucose infusion-rate curve of insulin aspart [0 - 8 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Diagnosis of type 1 diabetes for at least 12 months

    2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months

    3. HbA1c concentration ≤8.5% at screening

    4. Weight within the range 75kg - 100kg (both inclusive)

    Exclusion Criteria:

    1. Known or suspected hypersensitivity to Investigational Medicinal Products

    2. Clinically significant concomitant disease or abnormal lab values

    3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trials Unit, Medical University of Graz Graz Austria

    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:
    NCT04660305
    Other Study ID Numbers:
    • ARE-278-102
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin Aspart

    Study Results

    No Results Posted as of Jul 21, 2021