The company Arecor Limited is commencing recruitment for the clinical trial of the AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study. The location is Austria.
The trial officially began on the February 17, 2023 and is planned to complete on November 25, 2023.
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.
The population that can be enrolled into this study includes:
- 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)
- 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.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05754424