NCT05184868

AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Arecor Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	AT247	Ultra rapid acting prandial insulin aspart
DRUG	NovoLog	Rapid acting prandial insulin aspart
DRUG	Fiasp	Fast acting prandial insulin aspart

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2022-01-11
• Last updated: 2022-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study