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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003974-65 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial part 1 | Experimental |
| |
| Trial part 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (trial part 1 only) | From day prior to dosing and until 10-14 days after dosing | |
| Area under the glucose infusion rate curve (trial part 2 only) | 0-24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration curve | 0-72 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 | Ascending single doses - 5 dose levels |
|
| insulin degludec | Drug | A single dose corresponding to that of isophane human insulin |
|
| isophane human insulin | Drug | A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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