AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959514
• Other study ID #: ARE-247-101
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2019
• Est. completion date: August 8, 2019

Study information

• Verified date: September 2019
• Source: Arecor Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 8, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria include:

1. Diagnosis type I Diabetes Mellitus for at least 12 months

2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months

3. Fasting C-peptide concentration =8.5% (=69 mmol/mol) at screening

4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

1. known or suspected hypersensitivity to Investigational Medicinal Products

2. clinically significant concomitant disease or abnormal lab values

3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• NovoRapid
Rapid acting prandial insulin aspart
• Fiasp
Fast acting prandial insulin aspart
• AT247
Ultra rapid acting prandial insulin aspart

Locations

Country	Name	City	State
Austria	Clinical Research Centre	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Arecor Limited

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate-time curve of insulin aspart		0-60 minutes
Secondary	Area under the serum insulin aspart concentration-time curve from 0-60 minutes		0-60 minutes