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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008306-43 | EudraCT Number | ||
| U1111-1112-4715 | Other Identifier | WHO |
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This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1, first period | Experimental |
| |
| A2, second period | Active Comparator |
| |
| B1, first period | Active Comparator |
| |
| B2, second period | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | 0.4 U/kg body weight injected subcutaneously (under the skin), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NN1250 concentration-time curve after single dose | 0-72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed NN1250 concentration after single dose | 0-72 hours after dosing | |
| Time to maximum observed NN1250 concentration after single dose | 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Hanover | 30173 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24467565 | Result | Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Sondergaard F, Kristensen NR, Haahr H, Danne T. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Feb;15(1):27-33. doi: 10.1111/pedi.12116. |
| 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 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin glargine | Drug | 0.4 U/kg body weight injected subcutaneously (under the skin), single dose |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |