NCT05754424

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Arecor Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	AT278	Concentrated rapid acting insulin aspart
DRUG	NovoRapid	Rapid-acting insulin aspart
DRUG	Humulin R 500 UNT/ML Injectable Solution	Regular human insulin

Timeline

• Start date: 2023-02-27
• Primary completion: 2024-01-18
• Completion: 2024-02-12
• First posted: 2023-03-03
• Last updated: 2024-02-16

Locations

1 site across 1 country: Austria