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OpenTrials
Completed

NCT Number: NCT05754424

AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

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 2 diabetes for at least 180 days prior to the day of screening
  • Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
  • BMI within the range of 25 - 45 kg/m2 (both inclusive)

Exclusion criteria

  • Known or suspected hypersensitivity to IMPs or related products
  • Clinically significant concomitant disease or abnormal lab values
  • Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Treatment and study plan

AT278

Drug

Concentrated rapid acting insulin aspart

NovoRapid

Drug

Rapid-acting insulin aspart

Humulin R 500 UNT/ML Injectable Solution

Drug

Regular human insulin

Primary outcomes

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

    Time frame: 0 to 60 minutes

Sponsors and collaborators

Lead sponsor

Arecor Limited

Industry

Registry information

Official study title

A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2023
Registry last updated
Feb 16, 2024

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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