AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Overview

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.

Full Title of Study: “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).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 30, 2019

Interventions

  • Biological: NovoRapid
    • Rapid acting prandial insulin aspart
  • Biological: Fiasp
    • Fast acting prandial insulin aspart
  • Biological: AT247
    • Ultra rapid acting prandial insulin aspart

Arms, Groups and Cohorts

  • Experimental: AT247
    • Single subcutaneous injection 0.3 U/Kg
  • Active Comparator: NovoRapid
    • Single subcutaneous injection 0.3 U/Kg
  • Active Comparator: Fiasp
    • Single subcutaneous injection 0.3 U/Kg

Clinical Trial Outcome Measures

Primary Measures

  • Area under the glucose infusion rate-time curve of insulin aspart
    • Time Frame: 0-60 minutes

Secondary Measures

  • Area under the serum insulin aspart concentration-time curve from 0-60 minutes
    • Time Frame: 0-60 minutes

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arecor Limited
  • Provider of Information About this Clinical Study
    • Sponsor

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