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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005538-11 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U200 | Experimental |
| |
| U100 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | Drug | A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) in the interval of 0-6 hours | ||
| Cmax, maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC in the interval of 0-infinity hours | ||
| tmax, time to reach Cmax | ||
| Terminal rate constant |
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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 | Hvidovre | 2650 | Denmark |
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| 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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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Vz/f, volume of distribution during terminal phase |
| t½, terminal half-life |
| AUCGIR, area under the glucose infusion rate value curve |
| GIRmax, maximum glucose infusion rate value |
| tGIRmax, time to maximum glucose infusion rate value |
| Adverse events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |