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

Arecor

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: NovoRapid; Drug: Humulin R 500 UNT/ML Injectable Solution; Drug: AT278

Study type: Interventional

Funder types: Industry

Identifiers

NCT05754424

2022-001984-28 (EudraCT Number)

ARE-278-104

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

AT278

Experimental group

Description:

Single subcutaneous injection of 0.5 U/kg

Treatment:

Drug: AT278

Drug: NovoRapid

Drug: Humulin R 500 UNT/ML Injectable Solution

NovoRapid

Active Comparator group

Description:

Single subcutaneous injection of 0.5 U/kg

Treatment:

Drug: AT278

Drug: NovoRapid

Drug: Humulin R 500 UNT/ML Injectable Solution