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NCT04660305 Clinical Trial

AT278 and NovoRapid® in Glucose Clamp Study

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04660305
Other study ID # ARE-278-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2, 2020
Est. completion date June 11, 2021

Study information
Verified date December 2020
Source Arecor Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date June 11, 2021
Est. primary completion date June 3, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: 1. Diagnosis of type 1 diabetes for at least 12 months 2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months 3. HbA1c concentration =8.5% at screening 4. Weight within the range 75kg - 100kg (both inclusive) Exclusion Criteria: 1. Known or suspected hypersensitivity to Investigational Medicinal Products 2. Clinically significant concomitant disease or abnormal lab values 3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AT278
Concentrated rapid acting insulin aspart
• NovoRapid
Rapid acting insulin aspart

Locations
Country Name City State
Austria Clinical Trials Unit, Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Arecor Limited

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the glucose infusion-rate curve of insulin aspart 0 - 8 hours
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