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NCT05754424 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05754424
Other study ID # ARE-278-104
Secondary ID 2022-001984-28
Status Completed
Phase Phase 1
First received
Last updated
Start date February 27, 2023
Est. completion date February 12, 2024

Study information
Verified date February 2024
Source Arecor Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date February 12, 2024
Est. primary completion date January 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening - Haemoglobin A1C (HbA1c) concentration of =9.5% (=80 mmol/mol) at screening. - BMI within the range of 25 - 45 kg/m2 (both inclusive) Exclusion Criteria: - Known or suspected hypersensitivity to IMPs or related products - Clinically significant concomitant disease or abnormal lab values - Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AT278
Concentrated rapid acting insulin aspart
• NovoRapid
Rapid-acting insulin aspart
• Humulin R 500 UNT/ML Injectable Solution
Regular human insulin

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-time curve of insulin aspart 0 to 60 minutes
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