AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Study Overview
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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.

Official Title
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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).

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Biological: NovoRapid
* Biological: Fiasp
* Biological: AT247


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT247<br>Single subcutaneous injection 0.3 U/Kg | Biological: NovoRapid<br>* Rapid acting prandial insulin aspart<br>* Other names: NovoLog;Biological: Fiasp<br>* Fast acting prandial insulin aspart<br>Biological: AT247<br>* Ultra rapid acting prandial insulin aspart<br>|
| Active Comparator: NovoRapid<br>Single subcutaneous injection 0.3 U/Kg | Biological: NovoRapid<br>* Rapid acting prandial insulin aspart<br>* Other names: NovoLog;Biological: Fiasp<br>* Fast acting prandial insulin aspart<br>Biological: AT247<br>* Ultra rapid acting prandial insulin aspart<br>|
| Active Comparator: Fiasp<br>Single subcutaneous injection 0.3 U/Kg | Biological: NovoRapid<br>* Rapid acting prandial insulin aspart<br>* Other names: NovoLog;Biological: Fiasp<br>* Fast acting prandial insulin aspart<br>Biological: AT247<br>* Ultra rapid acting prandial insulin aspart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate-time curve of insulin aspart |  | 0-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve from 0-60 minutes |  | 0-60 minutes |