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This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mcg/kg | Experimental |
| |
| 20 mcg/kg | Experimental |
| |
| 25 mcg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | ||
| Body weight | ||
| Antibody against liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma liraglutide concentration curve | ||
| Cmax, maximum concentration | ||
| tmax, time to reach Cmax |
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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 | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18541123 | Result | Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S. Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Int J Clin Pharmacol Ther. 2008 Jun;46(6):273-9. doi: 10.5414/cpp46273. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| liraglutide | Drug | One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks |
|
| liraglutide | Drug | One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks |
|
| placebo | Drug | Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1 |
|
| Terminal elimination rate constant |
| t½, terminal elimination half-life |
| 24-hour profiles of plasma glucose |
| 24-hour profiles of serum insulin |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |