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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000097-20 | EudraCT Number |
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This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin degludec | Experimental |
| |
| IDegAsp | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration-time curve (for insulin degludec) | 0-120 hours after dosing | |
| Maximum serum insulin degludec concentration (Cmax) (for insulin degludec) | 0-120 hours after dosing | |
| Area under the serum insulin aspart concentration-time curve (for IDegAsp) | 0-10 hours after dosing | |
| Maximum serum insulin aspart concentration (Cmax) (for IDegAsp) | 0-10 hours after dosing | |
| Area under the serum insulin degludec concentration-time curve (for IDegAsp) | 0-120 hours after dosing | |
| Maximum serum insulin degludec concentration (Cmax) (for IDegAsp) | 0-120 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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| insulin degludec/insulin aspart | Drug | Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, 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 |
| C578220 | insulin degludec, insulin aspart drug combination |
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