drugset / Trial / NCT05754424
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |