Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014555-68 | EudraCT Number | ||
| U1111-1112-7714 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg 100 U/mL | Experimental |
| |
| IDeg 200 U/mL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve during one dosing interval at steady-date" | After 8 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum Insulin Degludec concentration-time curve | During one dosing interval at steady state | |
| Area under the serum Insulin Degludec concentration-time curve | From 0 to 24 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 | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23749405 | Result | Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| insulin degludec | Drug | 0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days. |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |