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

NCT05754424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-02-16

No results posted yet for this study

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

DRUG

AT278

Concentrated rapid acting insulin aspart

DRUG

NovoRapid

Rapid-acting insulin aspart

DRUG

Humulin R 500 UNT/ML Injectable Solution

Regular human insulin

Sponsors & Collaborators

  • Arecor Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754424 on ClinicalTrials.gov