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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002590-32 | EudraCT Number | ||
| U1111-1121-8351 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIAsp | Experimental | Each subject will be randomised to a treatment sequence consisting of 5 treatment periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster-acting insulin aspart | Drug | Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration) | From 0 to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve (only for intramuscular administration) | From 0 to 12 hours | |
| Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration) | From 0 to 12 hours |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28185141 | Result | Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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