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

NCT ID: NCT05754424

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2024-02-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AT278

Single subcutaneous injection of 0.5 U/kg

Group Type EXPERIMENTAL

AT278

Intervention Type DRUG

Concentrated rapid acting insulin aspart

NovoRapid

Intervention Type DRUG

Rapid-acting insulin aspart

Humulin R 500 UNT/ML Injectable Solution

Intervention Type DRUG

Regular human insulin

NovoRapid

Single subcutaneous injection of 0.5 U/kg

Group Type ACTIVE_COMPARATOR

AT278

Intervention Type DRUG

Concentrated rapid acting insulin aspart

NovoRapid

Intervention Type DRUG

Rapid-acting insulin aspart

Humulin R 500 UNT/ML Injectable Solution

Intervention Type DRUG

Regular human insulin

Interventions

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AT278

Concentrated rapid acting insulin aspart

Intervention Type DRUG

NovoRapid

Rapid-acting insulin aspart

Intervention Type DRUG

Humulin R 500 UNT/ML Injectable Solution

Regular human insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arecor Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trials Unit, Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2022-001984-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARE-278-104

Identifier Type: -

Identifier Source: org_study_id

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