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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000216-34 | EudraCT Number | ||
| U1111-1152-1391 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 0.6 mg s.c. with FlexPen® | Experimental |
| |
| Liraglutide 0.6 mg s.c. with the PDS290 pen-injector | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose | 0-72 hours following administration of 0.6 mg liraglutide | |
| Maximum observed liraglutide plasma concentration after single dose | 0-72 hours following administration of 0.6 mg liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2 |
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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 | Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |