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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-9348 | Other Identifier | WHO | |
| 2010-019641-26 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IAsp | Experimental |
| |
| IDeg | Experimental |
| |
| IDegAsp | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve | From 0 to 6 hours after single-dose (only for IDeg and IDegAsp) | |
| Area under the glucose infusion rate curve | From 6 to 24 hours after single-dose (only for IDegAsp and IAsp) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration-time curve | From 0 to 120 hours after single-dose (only for IDeg and IDegAsp) | |
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours after single-dose (only for IDegAsp and IAsp) |
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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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| 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 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin degludec/insulin aspart | Drug | Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin). |
|
| insulin aspart | Drug | Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin). |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |