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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-8843 | Other Identifier | WHO | |
| 2008-008356-16 | EudraCT Number |
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This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.
The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDeg | Experimental |
| |
| IGlar | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration | Within 0-46 hours after last trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose | Within 0-46 hours after last trial product administration | |
| Time from start of hypoglycaemic induction until each level of plasma glucose is reached | Within 0-46 hours after last trial product administration |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24057153 | Result | Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin glargine | Drug | Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement. |
|
| Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L | Within 0-46 hours after last trial product administration |
| Hypoglycaemic symptoms score during recovery from hypoglycaemia | Within 0-46 hours after last trial product administration |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |