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This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Placebo Comparator |
| |
| B1 | Experimental |
| |
| B2 | Placebo Comparator |
| |
| C1 | Experimental |
| |
| C2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Liraglutide for s.c. injection once daily: dose step 1 (9 subjects) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing. | After 21 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1) | After 1 day of treatment | |
| Adverse events | After 21 days of treatment | |
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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 | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21273395 | Result | Jiang J, Zhang J, Jacobsen LV, Hu P. The pharmacokinetics, pharmacodynamics, and tolerability of liraglutide, a once-daily human GLP-1 analogue, after multiple subcutaneous administration in healthy Chinese male subjects. J Clin Pharmacol. 2011 Dec;51(12):1620-7. doi: 10.1177/0091270010389468. Epub 2011 Jan 27. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo |
| Drug |
Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects) |
|
| liraglutide | Drug | Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects) |
|
| placebo | Drug | Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects) |
|
| liraglutide | Drug | Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects) |
|
| placebo | Drug | Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects) |
|
| Hypoglycaemic events |
| After 21 days of treatment |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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