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OpenTrials
Completed

NCT Number: NCT04660305

AT278 and NovoRapid® in Glucose Clamp Study

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

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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 Trials Unit, Medical University of Graz

Graz, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 1 diabetes for at least 12 months
  • Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
  • HbA1c concentration ≤8.5% at screening
  • Weight within the range 75kg - 100kg (both inclusive)

Exclusion criteria

  • Known or suspected hypersensitivity to Investigational Medicinal Products
  • Clinically significant concomitant disease or abnormal lab values
  • Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Treatment and study plan

AT278

Drug

Concentrated rapid acting insulin aspart

NovoRapid

Drug

Rapid acting insulin aspart

Other names: NovoLog

Primary outcomes

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

    Time frame: 0 - 8 hours

Sponsors and collaborators

Lead sponsor

Arecor Limited

Industry

Registry information

Official study title

Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2020
Registry last updated
Jul 21, 2021

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.

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