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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001569-42 | EudraCT Number | ||
| U1111-1120-3922 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 | Experimental |
| |
| Formulation 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration-time curve | From 0 to 120 hours after single-dose (SD) | |
| Maximum observed serum insulin degludec concentration | After single-dose (within 0 to 120 hours after dosing) | |
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours after single-dose | |
| Maximum observed serum insulin aspart concentration | After single-dose (within 0 to 12 hours after dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve | From 0 to 26 hours after single-dose | |
| Maximum glucose infusion rate | After single-dose (within 0 to 120 hours after 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 |
|---|---|---|---|---|---|---|
| Graz | 8010 | Austria |
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| 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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |