AT278 and NovoRapid® in Glucose Clamp Study

Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04660305

Enrollment

Registered

2020-12-09

Start date

2020-12-02

Completion date

2021-06-11

Last updated

2021-07-21

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

Conditions

Diabetes Mellitus, Type 1

Brief summary

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Interventions

DRUGAT278

Concentrated rapid acting insulin aspart

DRUGNovoRapid

Rapid acting insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of type 1 diabetes for at least 12 months 2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months 3. HbA1c concentration ≤8.5% at screening 4. Weight within the range 75kg - 100kg (both inclusive)

Exclusion criteria

1. Known or suspected hypersensitivity to Investigational Medicinal Products 2. Clinically significant concomitant disease or abnormal lab values 3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion-rate curve of insulin aspart	0 - 8 hours

Countries

Austria

Outcome results

None listed

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