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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002212-97 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Once-daily dosing regimen, high concentration) | Experimental |
| |
| Part 2 (Twice-daily dosing regimen, high concentration) | Experimental |
| |
| Part 3 (Once-daily dosing regimen, low concentration) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Administered subcutaneously (s.c., under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve | 0-24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum glucose infusion rate (GIRmax) | 0-24 hours after dosing | |
| Time to maximum glucose infusion rate (tGIRmax) | 0-24 hours after dosing | |
| Area under the serum insulin degludec 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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| 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 |
|---|---|
| C571886 | insulin degludec |
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| 0-96 hours after dosing |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |