Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003534-41 | EudraCT Number |
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 was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental |
| |
| Medium dose | Experimental |
| |
| High dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the glucose infusion rate curve | 0-24 hours in steady-state |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration curve at steady state | 0-24 hours after dosing |
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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
Not provided
| 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 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| insulin glargine | Drug | Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment. |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |