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AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

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ClinicalTrials.gov Identifier: NCT03959514
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Arecor Limited

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE April 12, 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Area under the glucose infusion rate-time curve of insulin aspart [ Time Frame: 0-60 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Area under the serum insulin aspart concentration-time curve from 0-60 minutes [ Time Frame: 0-60 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AT247, NovoRapid® and Fiasp® in Glucose Clamp Study
Official Title  ICMJE 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).
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Biological: NovoRapid
    Rapid acting prandial insulin aspart
    Other Name: NovoLog
  • Biological: Fiasp
    Fast acting prandial insulin aspart
  • Biological: AT247
    Ultra rapid acting prandial insulin aspart
Study Arms  ICMJE
  • Experimental: AT247
    Single subcutaneous injection 0.3 U/Kg
    Interventions:
    • Biological: NovoRapid
    • Biological: Fiasp
    • Biological: AT247
  • Active Comparator: NovoRapid
    Single subcutaneous injection 0.3 U/Kg
    Interventions:
    • Biological: NovoRapid
    • Biological: Fiasp
    • Biological: AT247
  • Active Comparator: Fiasp
    Single subcutaneous injection 0.3 U/Kg
    Interventions:
    • Biological: NovoRapid
    • Biological: Fiasp
    • Biological: AT247
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria include:

  1. Diagnosis type I Diabetes Mellitus for at least 12 months
  2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
  3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
  4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

  1. known or suspected hypersensitivity to Investigational Medicinal Products
  2. clinically significant concomitant disease or abnormal lab values
  3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eva Svehlikova, MD + 43 316-385-72835 eva.svehlilkova@medunigraz.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959514
Other Study ID Numbers  ICMJE ARE-247-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arecor Limited
Study Sponsor  ICMJE Arecor Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arecor Limited
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP