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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-2896 | Other Identifier | WHO | |
| JapicCTI-132253 | Registry Identifier | JAPIC |
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This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIAsp | Experimental | Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits |
|
| NovoRapid® | Active Comparator | Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster-acting insulin aspart | Drug | Single dose injected subcutaneously (s.c, under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0-1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0-12 hours | |
| Area under the glucose infusion rate (GIR) curve | From 0-1 hour | |
| Area under the glucose infusion rate (GIR) curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Fukuoka | 812-0025 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28556616 | Background | Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2):303-310. doi: 10.1111/jdi.12697. Epub 2017 Jul 7. | |
| 30402720 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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| insulin aspart | Drug | Single dose injected subcutaneously (s.c, under the skin) |
|
| From 0-12 hours |
| Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |