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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021190-36 | EudraCT Number | ||
| U1111-1119-2417 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of insulin degludec and liraglutide, when administered either combined or as separate administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegLira | Experimental |
| |
| IDeg | Active Comparator |
| |
| Lira | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits. |
| Measure | Description | Time Frame |
|---|---|---|
| The area under insulin degludec concentration-time curve | from 0-infinity hours after trial product administration | |
| The area under liraglutide concentration-time curve | from 0-infinity hours after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| The area under insulin degludec concentration-time curve | from 0-120 hours after trial product administration | |
| The area under liraglutide concentration-time curve | from 0-72 hours after 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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
| C000613158 | IDegLira |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| insulin degludec/liraglutide | Drug | Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits. |
|
| liraglutide | Drug | Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits. |
|
| Maximum concentration of insulin degludec | from 0-120 hours after trial product administration |
| Maximum concentration of liraglutide | from 0-72 hours after trial product administration |
| Number of hypoglycaemic episodes | From day 0 to 7-14 days after 3rd trial product administration |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |