ClinicalTrials.Veeva

Menu

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

A

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Eva Svehlikova, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems