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Recruiting
NCT05754424
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1
Enrollment: 32
Sponsor: Arecor Limited
Location: Austria
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.
Eligibility Criteria
Inclusion Criteria:Diagnosis of type 2 diabetes for at least 180 days prior to the day of screeningHaemoglobin 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 productsClinically significant concomitant disease or abnormal lab valuesSevere asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Source: ClinicalTrials.gov (NCT05754424). StuddyBuddy aggregates publicly available trial information.