Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-6874 | Other Identifier | WHO | |
| 2009-016779-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| HNEC TEST | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NN5401 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin degludec concentration-time curve | from 0 to infinity after single-dose | |
| Area under the serum insulin aspart concentration-time curve | from 0 to 12 hours after single-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed | from 0 to 57 hours after single-dose | |
| Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed | from 0 to 12 hours after single-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Hanover | 30173 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26782928 | Result | Biester T, Danne T, Blasig S, Remus K, Aschemeier B, Kordonouri O, Bardtrum L, Haahr H. Pharmacokinetic and prandial pharmacodynamic properties of insulin degludec/insulin aspart in children, adolescents, and adults with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):642-649. doi: 10.1111/pedi.12358. Epub 2016 Jan 18. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
Not provided
Not provided
Not provided