NCT05754424CompletedPhase 1
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.
Source: ClinicalTrials.gov · Last updated 16 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 21 Feb 2023
- Start date
- 27 Feb 2023
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Arecor Limited
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05754424
- EudraCT number
- 2022-001984-28
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 41
- From 27 Feb 2023 to the primary completion date, 18 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known or suspected hypersensitivity to IMPs or related products
- Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Lab values
- Clinically significant concomitant disease or abnormal lab values
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trials Unit, Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
Related publications
- A New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra-Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI.Diabetes Obes Metab · 2026 · PMID 42530378
This page is information, not medical advice. Discuss any trial with your doctor.