Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT01817569
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Specific Clinical Experience Investigation for long-term use of exenatide (Byetta subcutaneous injection).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2948
- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event incidence. 3 years Number of Adverse Drug Reactions
- Secondary Outcome Measures
Name Time Method Mean change in weight. 3 years Mean change of HbA1c. 3 years Change value of HbA1c from baseline as mean / median / minimum / max.
Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs). 3 years 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.
Mean change in blood pressure. 3 years. Mean change in lipid metabolism. 3 years Change value of lipid metabolism from baseline as mean / median / minimum / max.
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan