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

• Status: Recruiting
• Trial end date: 2023-11-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arecor Limited
• Treatments: Insulin Aspart

Criteria

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