NCT01940770已完成不适用
Specific Clinical Experience Investigation for Long-term Use of Bydureon Subcutaneous Injection 2 mg and Bydureon Subcutaneous Injection 2 mg PEN
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,137
- 试验地点
- 1
- 主要终点
- Adverse event incidence
研究概览
简要总结
To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adverse event incidence
时间窗: 3 years
Number of Adverse Drug Reactions
次要结局
- Mean change of HbA1c(from baseline up to 3 years)
- Mean change of weight(from baseline up to 3 years)
- Mean change of blood pressure(from baseline up to 3 years)
- Mean change of lipid metabolism(from baseline up to 3 years)
研究者
研究点 (1)
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