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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: AT278; Drug: NovoRapid; Drug: Humulin R 500 UNT/ML Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eva Svehlikova, MD; Phone Number: +43 316 385 80416; Email: eva.svehlilkova@medunigraz.at

Study Locations

• Austria
  • Graz, Austria
    • Clinical Trials Unit, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT278; Single subcutaneous injection of 0.5 U/kg	Drug: AT278; Concentrated rapid acting insulin aspart; Drug: NovoRapid; Rapid-acting insulin aspart; Drug: Humulin R 500 UNT/ML Injectable Solution; Regular human insulin
Active Comparator: NovoRapid; Single subcutaneous injection of 0.5 U/kg	Drug: AT278; Concentrated rapid acting insulin aspart; Drug: NovoRapid; Rapid-acting insulin aspart; Drug: Humulin R 500 UNT/ML Injectable Solution; Regular human insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the glucose infusion rate-time curve of insulin aspart	0 to 60 minutes

Collaborators and Investigators

• Sponsor: Arecor Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: ARE-278-104; 2022-001984-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No