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The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1:Type 2 diabetic patients treated with Exenatide therapy | Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus | At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in Hemoglobin A1c (HbA1c) | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks | |
| Change from baseline to endpoint in Body weight | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic, hospital and teaching hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Seoul | 110-756 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29065865 | Derived | Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4. |
| Label | URL |
|---|---|
| CSR\_Synopsis\_MB001-078.pdf | View source |
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| Change from baseline to endpoint in Fasting plasma glucose | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks |
| Change from baseline to endpoint in subjective measures include improvement of main indication | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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