AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Biological: NovoRapid; Biological: Fiasp; Biological: AT247

• Registration Number: NCT03959514
• Lead Sponsor: Arecor Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AT247	NovoRapid	Single subcutaneous injection 0.3 U/Kg
Fiasp	Fiasp	Single subcutaneous injection 0.3 U/Kg
AT247	AT247	Single subcutaneous injection 0.3 U/Kg
NovoRapid	NovoRapid	Single subcutaneous injection 0.3 U/Kg
NovoRapid	AT247	Single subcutaneous injection 0.3 U/Kg
Fiasp	NovoRapid	Single subcutaneous injection 0.3 U/Kg
NovoRapid	Fiasp	Single subcutaneous injection 0.3 U/Kg
Fiasp	AT247	Single subcutaneous injection 0.3 U/Kg
AT247	Fiasp	Single subcutaneous injection 0.3 U/Kg

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate-time curve of insulin aspart	0-60 minutes

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve from 0-60 minutes	0-60 minutes

Trial Locations

Locations (1)

Clinical Research Centre; 🇦🇹 Graz, Austria