Type 2 Diabetes
Conditions
Keywords
Diabetes Mellitus (DM), Byetta, Exenatide
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).
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Patient diagnosed with Type 2 Diabetes Mellitus and who is naive patient with Byetta.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event incidence. | 3 years | Number of Adverse Drug Reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 weight. | 3 years | — |
| 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. |
Countries
Japan
Outcome results
None listed