AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

NCT ID: NCT03959514

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2019-08-08

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AT247

Single subcutaneous injection 0.3 U/Kg

Group Type EXPERIMENTAL

NovoRapid

Intervention Type BIOLOGICAL

Rapid acting prandial insulin aspart

Fiasp

Intervention Type BIOLOGICAL

Fast acting prandial insulin aspart

AT247

Intervention Type BIOLOGICAL

Ultra rapid acting prandial insulin aspart

NovoRapid

Single subcutaneous injection 0.3 U/Kg

Group Type ACTIVE_COMPARATOR

NovoRapid

Intervention Type BIOLOGICAL

Rapid acting prandial insulin aspart

Fiasp

Intervention Type BIOLOGICAL

Fast acting prandial insulin aspart

AT247

Intervention Type BIOLOGICAL

Ultra rapid acting prandial insulin aspart

Fiasp

Single subcutaneous injection 0.3 U/Kg

Group Type ACTIVE_COMPARATOR

NovoRapid

Intervention Type BIOLOGICAL

Rapid acting prandial insulin aspart

Fiasp

Intervention Type BIOLOGICAL

Fast acting prandial insulin aspart

AT247

Intervention Type BIOLOGICAL

Ultra rapid acting prandial insulin aspart

Interventions

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NovoRapid

Rapid acting prandial insulin aspart

Intervention Type BIOLOGICAL

Fiasp

Fast acting prandial insulin aspart

Intervention Type BIOLOGICAL

AT247

Ultra rapid acting prandial insulin aspart

Intervention Type BIOLOGICAL

Other Intervention Names

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NovoLog

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Arecor Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Centre

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 33328285 (View on PubMed)

Other Identifiers

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ARE-247-101

Identifier Type: -

Identifier Source: org_study_id

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