Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004215-31 | EudraCT Number | ||
| U1111-1134-6222 | 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 (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegAsp 15 | Experimental |
| |
| IDegAsp | Experimental |
| |
| IDeg | Experimental |
| |
| IAsp | Active Comparator |
| |
| IDeg + IAsp | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart 15 | Drug | Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve | From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum IDeg concentration-time curve | From 0 to 120 hours after single dose | |
| Area under the serum IAsp concentration-time curve | 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 |
|---|---|---|---|---|---|---|
| Graz | 8010 | Austria |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| insulin degludec/insulin aspart | Drug | Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW). |
|
|
| insulin degludec | Drug | Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW). |
|
| insulin aspart | Drug | Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW). |
|
| placebo | Drug | Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. |
|
| 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 |
|---|---|
| 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided