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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS19606 | Registry Identifier | ENCePP |
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The purpose of this investigation is to describe general safety profile of type II Diabetes Mellitus (DM) Japanese patients under exenatide therapy in real world medical practices
Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Byetta |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse event incidence. | Number of Adverse Drug Reactions | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of HbA1c. | Change value of HbA1c from baseline as mean / median / minimum / max. | 3 years |
| Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). |
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Inclusion Criteria:
- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
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Patients are eligible to be included in the study if they meet all of the following criteria:
The patient who is diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
The patient follows the PI of Byetta.
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Yoshida, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | D5550C00001 | Japan | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. Each of the 8 items are scored on a scale of 0-6 where 0= very dissatisfied and 6= very satisfied. The higher score, the greater satisfaction with the treatment.
| 3 years |
| Mean change in weight. | 3 years |
| Mean change in blood pressure. | 3 years. |
| Mean change in lipid metabolism. | Change value of lipid metabolism from baseline as mean / median / minimum / max. | 3 years |
| Akita |
| D5550C00001 |
| Japan |
| Research Site | Aomori | D5550C00001 | Japan |
| Research Site | Chiba | D5550C00001 | Japan |
| Research Site | Ehime | D5550C00001 | Japan |
| Research Site | Fukuoka | D5550C00001 | Japan |
| Research Site | Fukushima | D5550C00001 | Japan |
| Research Site | Gifu | D5550C00001 | Japan |
| Research Site | Gunma | D5550C00001 | Japan |
| Research Site | Hiroshima | D5550C00001 | Japan |
| Research Site | Hokkaido | D5550C00001 | Japan |
| Research Site | Hyōgo | D5550C00001 | Japan |
| Research Site | Ibaraki | D5550C00001 | Japan |
| Research Site | Ishikawa | D5550C00001 | Japan |
| Research Site | Kagawa | D5550C00001 | Japan |
| Research Site | Kagoshima | D5550C00001 | Japan |
| Research Site | Kanagawa | D5550C00001 | Japan |
| Research Site | Kochi | D5550C00001 | Japan |
| Research Site | Kumamoto | D5550C00001 | Japan |
| Research Site | Kyoto | D5550C00001 | Japan |
| Research Site | Mie | D5550C00001 | Japan |
| Research Site | Miyagi | D5550C00001 | Japan |
| Research Site | Miyazaki | D5550C00001 | Japan |
| Research Site | Nagano | D5550C00001 | Japan |
| Research Site | Nagasaki | D5550C00001 | Japan |
| Research Site | Nara | D5550C00001 | Japan |
| Research Site | Niigata | D5550C00001 | Japan |
| Research Site | Numakunai | D5550C00001 | Japan |
| Research Site | Okayama | D5550C00001 | Japan |
| Research Site | Okinawa | D5550C00001 | Japan |
| Research Site | Osaka | D5550C00001 | Japan |
| Research Site | Ōita | D5550C00001 | Japan |
| Research Site | Saga | D5550C00001 | Japan |
| Research Site | Saitama | D5550C00001 | Japan |
| Research Site | Shiga | D5550C00001 | Japan |
| Research Site | Shimane | D5550C00001 | Japan |
| Research Site | Shizuoka | D5550C00001 | Japan |
| Research Site | Tochigi | D5550C00001 | Japan |
| Research Site | Tokushima | D5550C00001 | Japan |
| Research Site | Tokyo | D5550C00001 | Japan |
| Research Site | Tottori | D5550C00001 | Japan |
| Research Site | Toyama | D5550C00001 | Japan |
| Research Site | Wakayama | D5550C00001 | Japan |
| Research Site | Yamagata | D5550C00001 | Japan |
| Research Site | Yamaguchi | D5550C00001 | Japan |
| Research Site | Yamanashi | D5550C00001 | Japan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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