A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center, Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes With Inadequate Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 320
- 试验地点
- 113
- 主要终点
- Demonstrate superiority of Revita DMR to sham in improving glycemic control
研究概览
简要总结
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Demonstrate superiority of Revita DMR to sham in improving glycemic control
时间窗: Baseline to Week 24
Change from baseline in HbA1c at Week 24
次要结局
- Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks(Baseline to Week 24)
- Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks(Baseline to Week 24)
- To demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks in those subjects on insulin at baseline(Baseline to Week 24)
- Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks(Baseline to Week 24)
- Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks(Baseline to Week 24)
- Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks(Baseline to Week 24)
- To demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks in those subjects on insulin at baseline(Baseline to Week 24)