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AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

NovoRapid

Fiasp

AT247

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria include:

Diagnosis type I Diabetes Mellitus for at least 12 months
Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

known or suspected hypersensitivity to Investigational Medicinal Products
clinically significant concomitant disease or abnormal lab values
supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg

Sites / Locations

Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

AT247

NovoRapid

Fiasp

Arm Description

Single subcutaneous injection 0.3 U/Kg

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate-time curve of insulin aspart

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03959514

First Posted

May 13, 2019

Last Updated

September 27, 2019

Sponsor

Arecor Limited

1. Study Identification

Unique Protocol Identification Number

NCT03959514

Brief Title

AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

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).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 12, 2019 (Actual)

Primary Completion Date

July 30, 2019 (Actual)

Study Completion Date

August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arecor Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AT247

Arm Type

Experimental

Arm Description

Single subcutaneous injection 0.3 U/Kg

Arm Title

NovoRapid

Arm Type

Active Comparator

Arm Description

Single subcutaneous injection 0.3 U/Kg

Arm Title

Fiasp

Arm Type

Active Comparator

Arm Description

Single subcutaneous injection 0.3 U/Kg

Intervention Type

Biological

Intervention Name(s)

NovoRapid

Other Intervention Name(s)

NovoLog

Intervention Description

Rapid acting prandial insulin aspart

Intervention Type

Biological

Intervention Name(s)

Fiasp

Intervention Description

Fast acting prandial insulin aspart

Intervention Type

Biological

Intervention Name(s)

AT247

Intervention Description

Ultra rapid acting prandial insulin aspart

Primary Outcome Measure Information:

Title

Area under the glucose infusion rate-time curve of insulin aspart

Time Frame

0-60 minutes

Secondary Outcome Measure Information:

Title

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

Time Frame

0-60 minutes

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria include: Diagnosis type I Diabetes Mellitus for at least 12 months Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening BMI 18.5-35.0 kg/m2 Exclusion Criteria include: known or suspected hypersensitivity to Investigational Medicinal Products clinically significant concomitant disease or abnormal lab values supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg

Facility Information:

Facility Name

Clinical Research Centre

City

Graz

ZIP/Postal Code

8010

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

33328285

Citation

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.

Results Reference

derived

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AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

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