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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004081-15 | EudraCT Number | ||
| U1111-1123-6692 | Other Identifier | WHO |
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This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NN1218 | Experimental |
| |
| insulin aspart | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster-acting insulin aspart | Drug | Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours | |
| Maximum observed serum insulin aspart concentration | From 0 to 12 hours | |
| Time to maximum observed serum insulin aspart concentration |
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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 |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin aspart | Drug | At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin). |
|
| From 0 to 12 hours |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |