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

Phase 1

Completed

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

• Registration Number: NCT05754424
• Lead Sponsor: Arecor Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-21
• Study Start: 2023-02-27
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Primary Completion: 2024-01-18
• Status Verified: 2024-02
• Study Completion: 2024-02-12
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NovoRapid	NovoRapid	Single subcutaneous injection of 0.5 U/kg
AT278	Humulin R 500 UNT/ML Injectable Solution	Single subcutaneous injection of 0.5 U/kg
NovoRapid	Humulin R 500 UNT/ML Injectable Solution	Single subcutaneous injection of 0.5 U/kg
AT278	NovoRapid	Single subcutaneous injection of 0.5 U/kg
AT278	AT278	Single subcutaneous injection of 0.5 U/kg
NovoRapid	AT278	Single subcutaneous injection of 0.5 U/kg

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate-time curve of insulin aspart	0 to 60 minutes

Trial Locations

Locations (1)

Clinical Trials Unit, Medical University of Graz; 🇦🇹 Graz, Austria