Type 2 Diabetes Clinical Trial
Official title:
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
| Verified date | July 2020 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 2948 |
| Est. completion date | October 3, 2019 |
| Est. primary completion date | October 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Akita | |
| Japan | Research Site | Aomori | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Ehime | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukushima | |
| Japan | Research Site | Gifu | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Hiroshima | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ishikawa | |
| Japan | Research Site | Iwate | |
| Japan | Research Site | Kagawa | |
| Japan | Research Site | Kagoshima | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kumamoto | |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Mie | |
| Japan | Research Site | Miyagi | |
| Japan | Research Site | Miyazaki | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nara | |
| Japan | Research Site | Niigata | |
| Japan | Research Site | Oita | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saga | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shimane | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tochigi | |
| Japan | Research Site | Tokushima | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tottori | |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamaguchi | |
| Japan | Research Site | Yamanashi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse event incidence. | Number of Adverse Drug Reactions | 3 years | |
| Secondary | Mean change of HbA1c. | Change value of HbA1c from baseline as mean / median / minimum / max. | 3 years | |
| Secondary | Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). | 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 | |
| Secondary | Mean change in weight. | 3 years | ||
| Secondary | Mean change in blood pressure. | 3 years. | ||
| Secondary | Mean change in lipid metabolism. | Change value of lipid metabolism from baseline as mean / median / minimum / max. | 3 years |
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