AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Phase 1 Completed 18 enrolled Arecor Limited

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2019-04-12
Primary completion: 2019-07-30
Completion: 2019-08-08

Publications

Svehlikova E, Mursic I, Augustin T, Magnes C, Gerring D, Jezek J, Schwarzenbacher D, Ratzer M, Wolf M, Howell S, Zakrzewski L, Urschitz M, Tschapeller B, Gatschelhofer C, Feichtner F, Lawrence F, Pieber TR. Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double-Blind, Crossover Study in Men With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):448-455. doi: 10.2337/dc20-1017. Epub 2020 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AT247	Protein / enzyme biologic	0.3 iu/kg	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	0.3 iu/kg	Subcutaneous

AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Summary

Timeline

Publications

Drugs

Indications