Trials / Completed
CompletedNCT03959514
AT247, NovoRapid® and Fiasp® in Glucose Clamp Study
Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Arecor Limited · Industry
- Sex
- Male
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NovoRapid | Rapid acting prandial insulin aspart |
| BIOLOGICAL | Fiasp | Fast acting prandial insulin aspart |
| BIOLOGICAL | AT247 | Ultra rapid acting prandial insulin aspart |
Timeline
- Start date
- 2019-04-12
- Primary completion
- 2019-07-30
- Completion
- 2019-08-08
- First posted
- 2019-05-22
- Last updated
- 2019-09-30
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT03959514. Inclusion in this directory is not an endorsement.