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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005334-63 | EudraCT Number | ||
| U1111-1164-6630 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the 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 subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0143-0406 | Experimental |
| |
| Insulin Aspart | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0143-0406 | Drug | Subject will receive one single dose only Subcutanesously (s.c., under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of treatment emergent adverse events | From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum NNC0143-0406 concentration-time curve | From 0 to 24 hours | |
| Area under the glucose infusion rate-time curve | From 0 to 24 hours | |
| The maximum glucose infusion rate |
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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 | Graz | 8010 | Austria |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin aspart | Drug | Subject will receive one single dose only. Subcutanesously (s.c., under the skin) |
|
| From 0 to 24 hours |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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