drugset / Trial / NCT05754424

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

NCT05754424

Phase 1 Completed 41 enrolled Arecor Limited
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2023-02-27
Primary completion
2024-01-18
Completion
2024-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AT278 Protein / enzyme biologic 0.5 iu/kg Subcutaneous
Subject Insulin Protein / enzyme biologic 0.5 iu/kg Subcutaneous
Subject insulin aspart Protein / enzyme biologic 0.5 iu/kg Subcutaneous