Trial | NCT03959514  Report issue

Title

AT247, NovoRapid® and Fiasp® in Glucose Clamp 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).

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
Study Started
Apr 12
2019
Primary Completion
Jul 30
2019
Study Completion
Aug 08
2019
Last Update
Sep 30
2019

Biological NovoRapid

Rapid acting prandial insulin aspart

  • Other names: NovoLog

Biological Fiasp

Fast acting prandial insulin aspart

Biological AT247

Ultra rapid acting prandial insulin aspart

AT247 Experimental

Single subcutaneous injection 0.3 U/Kg

NovoRapid Active Comparator

Single subcutaneous injection 0.3 U/Kg

Fiasp Active Comparator

Single subcutaneous injection 0.3 U/Kg

Criteria 

Inclusion Criteria include:

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

Exclusion Criteria include:

known or suspected hypersensitivity to Investigational Medicinal Products
clinically significant concomitant disease or abnormal lab values
supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
No Results Posted