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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1132-2221 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of SADRs (Serious Adverse Drug Reactions) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (Glycosylated haemoglobin) change | Month 0, month 6 | |
| Percentage of subjects reaching the target of HbA1c below 7.0% | Month 6 | |
| Change in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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Victoza® will be prescribed and titrated by the physician.
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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 | Pyungchon-Dong 896, Dongan-Gu | 431-796 | South Korea | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Month 0, month 6 |
| Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions) | Up to 6 months |
| Seoul |
| 02447 |
| South Korea |
| Novo Nordisk Investigational Site | Seoul | 03080 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 150-950 | South Korea |
| Novo Nordisk Investigational Site | Ulsan | 44455 | South Korea |
| Novo Nordisk Investigational Site | Ulsan | 682-060 | South Korea |
| Novo Nordisk Investigational Site | Wŏnju | 220-701 | South Korea |
| 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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