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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003797-90 | EudraCT Number | ||
| U1111-1123-3837 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg-->IDegAsp | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve during one dosing interval | At steady state (0-24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum glucose infusion rate (GIRmax) | At steady state (within 0-24 hours after last dosing) | |
| Area under the serum insulin degludec concentration-time curve during one dosing interval | At steady state (within 0-24 hours after last 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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24888255 | Result | Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. doi: 10.1007/s13300-014-0070-2. Epub 2014 Jun 3. |
| 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 |
| C578220 | insulin degludec, insulin aspart drug combination |
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| insulin degludec/insulin aspart | Drug | Single dose administered subcutaneously (s.c., under the skin). |
|
| Maximum observed serum insulin degludec concentration | At steady state (within 0-24 hours after last dosing) |
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours |
| Maximum observed serum insulin aspart concentration | Within 0-12 hours after dosing of IDegAsp |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |