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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05754424

Enrollment

Registered

2023-03-03

Start date

2023-02-27

Completion date

2024-02-12

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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. 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.

Interventions

DRUGAT278

Concentrated rapid acting insulin aspart

DRUGNovoRapid

Rapid-acting insulin aspart

DRUGHumulin R 500 UNT/ML Injectable Solution

Regular human insulin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate-time curve of insulin aspart	0 to 60 minutes

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026