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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011959-53 | EudraCT Number |
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This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIBA 3W | Experimental |
| |
| SIBA OD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Insulin degludec injected s.c. (under the skin) three times weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of periods where carbohydrate supplementation is needed during the treatment | Assessed every day of the two in-house stays of nine days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | Assessed every day of the two in-house stays of nine days and one follow-up by telephone | |
| Number of periods with low blood sugar during treatment | Assessed every day of the two in-house stays of nine days and one follow-up by telephone |
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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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| insulin degludec |
| Drug |
Insulin degludec injected s.c. (under the skin) once daily for one week |
|
| placebo | Drug | Placebo injected s.c. (under the skin) four times weekly |
|
| 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 |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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