Specific Clinical Experience Investigation for Long-term Use of Bydureon.

Study Overview
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Brief Summary
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To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

Detailed Description
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To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use. Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices. Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated. Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction. Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy) Safety in patients with mild or moderate renal impairment Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc) Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)

Official Title
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Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise. Exclusion Criteria: No past history of hypersensitivity to the components of Bydureon. Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus. Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation. Not the patient with severe renal impairment, including those receiving dialysis.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence | Number of Adverse Drug Reactions | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of HbA1c | Change value of HbA1c from baseline as mean. | from baseline up to 3 years | 
| Mean change of weight | Change value of weight from baseline as mean. | from baseline up to 3 years | 
| Mean change of blood pressure | Change value of blood pressure from baseline as mean. | from baseline up to 3 years | 
| Mean change of lipid metabolism | Change value of lipid metabolism from baseline as mean. | from baseline up to 3 years | 
| Mean change of HbA1c | Change value of HbA1c from baseline as median. | from baseline up to 3 years | 
| Mean change of HbA1c | Change value of HbA1c from baseline as minimum. | from baseline up to 3 years | 
| Mean change of HbA1c | Change value of HbA1c from baseline as max. | from baseline up to 3 years | 
| Mean change of weight | Change value of weight from baseline as median. | from baseline up to 3 years | 
| Mean change of weight | Change value of weight from baseline as minimum. | from baseline up to 3 years | 
| Mean change of weight | Change value of weight from baseline as max. | from baseline up to 3 years | 
| Mean change of blood pressure | Change value of blood pressure from baseline as median. | from baseline up to 3 years | 
| Mean change of blood pressure | Change value of blood pressure from baseline as minimum. | from baseline up to 3 years | 
| Mean change of blood pressure | Change value of blood pressure from baseline as max. | from baseline up to 3 years | 
| Mean change of lipid metabolism | Change value of lipid metabolism from baseline as median. | from baseline up to 3 years | 
| Mean change of lipid metabolism | Change value of lipid metabolism from baseline as minimum. | from baseline up to 3 years | 
| Mean change of lipid metabolism | Change value of lipid metabolism from baseline as max. | from baseline up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus(DM), Bydureon, Exenatide