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
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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
Sites / Locations
- Clinical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
AT247
NovoRapid
Fiasp
Arm Description
Single subcutaneous injection 0.3 U/Kg
Single subcutaneous injection 0.3 U/Kg
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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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