临床试验/NCT01876849

NCT01876849已完成3 期

An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

AstraZeneca1 个研究点分布在 1 个国家目标入组 275 人开始时间: 2003年12月最近更新: 2015年2月24日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: AstraZeneca
入组人数: 275
试验地点: 1
主要终点: Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.

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: 30 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.

排除标准

•Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
•Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.

研究组 & 干预措施

Group A

Experimental

Exenatide injection 5mcg or 10 mcg, twice daily

干预措施: exenatide (Drug)

结局指标

主要结局

Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.

时间窗: 128 weeks (average treatment period)

Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.

次要结局

未报告次要终点

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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