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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017217-30 | EudraCT Number | ||
| U1111-1113-6783 | Other Identifier | WHO |
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This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg i.m. thigh | Experimental |
| |
| IDeg i.v. | Experimental |
| |
| IDeg s.c. abdomen | Experimental |
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| IDeg s.c. deltoid | Experimental |
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| IDeg s.c. thigh | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration) | From 0 to 120 hours after single-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration) | From 0 to 120 hours after single-dose | |
| Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration) | From 0 to 30 hours after single-dose |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25124362 | Result | Nosek L, Coester HV, Roepstorff C, Thomsen HF, Kristensen NR, Haahr H, Heise T. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region. Clin Drug Investig. 2014 Sep;34(9):673-9. doi: 10.1007/s40261-014-0218-x. |
| 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 |
|---|---|
| C571886 | insulin degludec |
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| Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration) | Within 0 to 120 hours after dosing |
| Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration) | At time zero after dosing |