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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT247 | Experimental | Single subcutaneous injection 0.3 U/Kg |
|
| NovoRapid | Active Comparator | Single subcutaneous injection 0.3 U/Kg |
|
| Fiasp | Active Comparator | Single subcutaneous injection 0.3 U/Kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoRapid | Biological | Rapid acting prandial insulin aspart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate-time curve of insulin aspart | 0-60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve from 0-60 minutes | 0-60 minutes |
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Inclusion Criteria include:
Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33328285 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Fiasp | Biological | Fast acting prandial insulin aspart |
|
| AT247 | Biological | Ultra rapid acting prandial insulin aspart |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |