Skip to main content
OpenTrials
Completed

NCT Number: NCT03959514

AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Centre

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoRapid

Biological

Rapid acting prandial insulin aspart

Other names: NovoLog

Fiasp

Biological

Fast acting prandial insulin aspart

AT247

Biological

Ultra rapid acting prandial insulin aspart

Primary outcomes

  1. Area under the glucose infusion rate-time curve of insulin aspart

    Time frame: 0-60 minutes

Secondary outcomes

  1. Area under the serum insulin aspart concentration-time curve from 0-60 minutes

    Time frame: 0-60 minutes

Sponsors and collaborators

Lead sponsor

Arecor Limited

Industry

Registry information

Official study 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).

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 22, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.