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AT278 and NovoRapid® in Glucose Clamp Study

NCT04660305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-07-21

No results posted yet for this study

Summary

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

AT278

Concentrated rapid acting insulin aspart

DRUG

NovoRapid

Rapid acting insulin aspart

Sponsors & Collaborators

  • Arecor Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2021-06-03
Completion
2021-06-11

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 NCT04660305 on ClinicalTrials.gov