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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005468-93 | EudraCT Number | ||
| U1111-1137-3809 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec/liraglutide, B5 | Experimental | Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. |
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| Insulin degludec/liraglutide, V2 | Experimental | Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | Subject will receive a single injection (s.c.) of IDegLira B5 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum IDeg concentration time curve after single dose | Assessed from 0 to 120 hours | |
| Maximum observed serum IDeg concentration after single dose | Assessed from 0-120 hours | |
| Area under the plasma liraglutide concentration time curve after single dose | Assessed from 0-72 hours | |
| Maximum observed plasma liraglutide concentration after single dose | Assessed from 0-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum IDeg concentration time curve after single dose | Assessed from 0-120 hours | |
| Time to maximum IDeg concentration | Assessed from 0-120 hours | |
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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/liraglutide | Drug | Subject will receive a single injection (s.c.) of IDegLira V2 |
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| Terminal elimination half-life for IDeg after single dose |
| Assessed from 0-120 hours |
| Area under the plasma liraglutide concentration time curve after single dose | Assessed from 0-72 hours |
| Time to maximum plasma liraglutide concentration after single dose | Assessed from 0-72 hours |
| Terminal elimination half-life of liraglutide after single dose | Assessed from 0-72 hours |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
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