AT247, NovoRapid® and Fiasp® in Glucose Clamp Study
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).
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedSeptember 30, 2019
September 1, 2019
4 months
May 13, 2019
September 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate-time curve of insulin aspart
0-60 minutes
Secondary Outcomes (1)
Area under the serum insulin aspart concentration-time curve from 0-60 minutes
0-60 minutes
Study Arms (3)
AT247
EXPERIMENTALSingle subcutaneous injection 0.3 U/Kg
NovoRapid
ACTIVE COMPARATORSingle subcutaneous injection 0.3 U/Kg
Fiasp
ACTIVE COMPARATORSingle subcutaneous injection 0.3 U/Kg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arecor Limitedlead
Study Sites (1)
Clinical Research Centre
Graz, 8010, Austria
Related Publications (1)
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.
PMID: 33328285DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 22, 2019
Study Start
April 12, 2019
Primary Completion
July 30, 2019
Study Completion
August 8, 2019
Last Updated
September 30, 2019
Record last verified: 2019-09