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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008472-14 | EudraCT Number | ||
| U1111-1111-9032 | Other Identifier | WHO |
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.
The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp low | Experimental |
| |
| IDegAsp middle | Experimental |
| |
| IDegAsp high | Experimental |
| |
| BIAsp 30 low | Experimental |
| |
| BIAsp 30 middle | Experimental |
| |
| BIAsp 30 high | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area (AUC) under the glucose infusion rate curve | From 0 to 24 hours after single-dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area (AUC) under the insulin aspart concentration time curve | From 0 to 24 hours after single-dose administration |
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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 |
|---|---|---|---|
| 25772444 | Result | Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. Epub 2015 May 1. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin degludec/insulin aspart | Drug | Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin) |
|
| insulin degludec/insulin aspart | Drug | Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin) |
|
| biphasic insulin aspart 30 | Drug | Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin) |
|
| biphasic insulin aspart 30 | Drug | Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin) |
|
| biphasic insulin aspart 30 | Drug | Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin) |
|
| 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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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