NCT02533453已完成4 期
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 110
- 试验地点
- 16
- 主要终点
- Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
研究概览
简要总结
As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 19-75 years of age
- •diagnosed with type 2 diabetes mellitus
- •Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;
- •Metformin
- •Sulphonylurea
- •Thiazolidinedione
- •Metformin and sulphonylurea
- •Metformin and thiazolidinedione
排除标准
- •Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
- •Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- •Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- •DPP-4 inhibitors within 30 days of screening;
- •Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
- •Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
- •GLP-1 receptor agonist except exenatide within 3 months of screening;
- •diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
- •type 2 diabetes by beta-cell dysfunction requiring insulin treatment
- •Has ever used exenatide
- •Pregnant or breast feeding patients
- •Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal
- •End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
研究组 & 干预措施
Bydureon
Experimental
exenatide once weekly
干预措施: Bydureon (Biological)
结局指标
主要结局
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
时间窗: baseline and 12/24 weeks
was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance.
次要结局
- Change in Fasting Plasma Gloucose(baseline and 12/24 weeks)
- Change in Body Weight(baseline and 12/24 weeks)
- Change in Vital Sign(baseline and 12/24 weeks)
- Evaluation of "Subjective Improvement of Main Indication"(baseline and 12/24 weeks)
- Change in HbA1c(baseline and 12/24 weeks)
研究者
研究点 (16)
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