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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002615-26 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose, insulin degludec | Experimental |
| |
| Medium dose, insulin degludec | Experimental |
| |
| High dose, insulin degludec | Experimental |
| |
| IDegAsp 50 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Single dose administered subcutaneously (s.c., under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | From dosing visit and until follow-up 7-21 days after last dosing visit |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration curve | 0-96 hours after dosing | |
| Area under the glucose infusion rate curve | 0-24 hours after dosing |
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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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Administered subcutaneously (s.c., under the skin) |
|
| insulin degludec/insulin aspart 50 | Drug | Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin) |
|
| 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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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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