Trials / Completed
CompletedNCT04660305
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Arecor Limited · Industry
- Sex
- Male
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AT278 | Concentrated rapid acting insulin aspart |
| DRUG | NovoRapid | Rapid acting insulin aspart |
Timeline
- Start date
- 2020-12-02
- Primary completion
- 2021-06-03
- Completion
- 2021-06-11
- First posted
- 2020-12-09
- Last updated
- 2021-07-21
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04660305. Inclusion in this directory is not an endorsement.