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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-9099 | Other Identifier | WHO | |
| 2009-017281-23 | EudraCT Number |
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg 100U/mL 0.4U/kg | Experimental |
| |
| IDeg 100U/mL 0.6U/kg | Experimental |
| |
| IDeg 100U/mL 0.8U/kg | Experimental |
| |
| IDeg 200U/mL 0.6U/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve from 0-24 hours at steady state | 0-24 hours (derived on treatment day 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin degludec concentration-time curve from 0-24 hours at steady state | 0-24 hours (derived on treatment day 6) |
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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 |
|---|---|---|---|
| 22726241 | Result | Heise T, Nosek L, Bottcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012 Oct;14(10):944-50. doi: 10.1111/j.1463-1326.2012.01638.x. Epub 2012 Jul 10. | |
| 25581159 | Result | Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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