AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

• ClinicalTrials.gov Identifier: NCT03959514
• Recruitment Status: Completed
• First Posted: May 22, 2019
• Last Update Posted: September 30, 2019
• Sponsor: Arecor Limited
• Information provided by (Responsible Party): Arecor Limited

Tracking Information

• First Submitted Date: May 13, 2019
• First Posted Date: May 22, 2019
• Last Update Posted Date: September 30, 2019
• Actual Study Start Date: April 12, 2019
• Actual Primary Completion Date: July 30, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 21, 2019): Area under the glucose infusion rate-time curve of insulin aspart [ Time Frame: 0-60 minutes ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AT247, NovoRapid® and Fiasp® in Glucose Clamp 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).
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 1

Intervention

• 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

• 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 *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 21, 2019): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 8, 2019
• Actual Primary Completion Date: July 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT03959514
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Arecor Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Arecor Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Arecor Limited
• Verification Date: September 2019