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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-7056 | Other Identifier | WHO | |
| 2009-015646-30 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NN5401 - low dose | Experimental |
| |
| NN5401 - medium dose | Experimental |
| |
| NN5401 - high dose | Experimental |
| |
| biphasic insulin aspart 30 - low dose | Active Comparator |
| |
| biphasic insulin aspart 30 - medium dose | Active Comparator |
| |
| biphasic insulin aspart 30 - high dose | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | 0.4 U/kg body weight injected subcutaneously (under the skin) once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve (only for IDegAsp) | From 0 to 24 hours after single-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin aspart concentration-time curve | From 0 to 12 hours after single-dose administration | |
| Area under the insulin aspart concentration-time curve (only for BIAsp 30) | 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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin degludec/insulin aspart | Drug | 0.6 U/kg body weight injected subcutaneously (under the skin) once |
|
| insulin degludec/insulin aspart | Drug | 0.8 U/kg body weight injected subcutaneously (under the skin) once |
|
| biphasic insulin aspart 30 | Drug | 0.4 U/kg body weight injected subcutaneously (under the skin) once |
|
| biphasic insulin aspart 30 | Drug | 0.6 U/kg body weight injected subcutaneously (under the skin) once |
|
| biphasic insulin aspart 30 | Drug | 0.8 U/kg body weight injected subcutaneously (under the skin) once |
|
| 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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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