NCT01817569CompletedNot Applicable
Specific Clinical Experience Investigation for Long-term Use of Exenatide (Byetta Subcutaneous Injection)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 2,948
- Locations
- 1
- Primary Endpoint
- Adverse event incidence.
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adverse event incidence.
Time Frame: 3 years
Number of Adverse Drug Reactions
Secondary Outcomes
- Mean change in weight.(3 years)
- Mean change of HbA1c.(3 years)
- Amount of change of total score of Diabetes Treatment Satisfaction Questionnaire (DTSQs).(3 years)
- Mean change in blood pressure.(3 years.)
- Mean change in lipid metabolism.(3 years)
Investigators
Study Sites (1)
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