NCT00986349已完成不适用
A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes
Morphic Medical Inc.2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Assessment of Glycemic Control (HbA1c) Over Time
研究概览
简要总结
The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects Age > 18 years and ≤ 55 years
- •Male or Female
- •Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
- •Subjects with an HbA1C > 7.5 and ≤ 10.0%
- •Subjects with a BMI > 26 - < 50
- •Subjects willing to comply with study requirements
- •Subjects who have signed an informed consent form
- •Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.
排除标准
- •Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- •Subjects requiring insulin
- •Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL)
- •Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
- •Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
- •Subjects requiring prescription anticoagulation therapy
- •Subjects with or a history of iron deficiency and/or iron deficiency anemia
- •Subjects with or a history of abnormalities of the GI tract
- •Subjects with symptomatic gallstones or kidney stones at the time of screening
- •Subjects with a known infection
- •Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the Subject a poor candidate for device placement or clinical trial participation
- •Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
- •Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- •Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
- •Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- •Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Subjects with active and uncontrolled GERD
- •Subjects with a known history of substance abuse
- •Subjects participating in another ongoing investigational clinical trial
- •Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
结局指标
主要结局
Assessment of Glycemic Control (HbA1c) Over Time
时间窗: Baseline to 12 Months with device implanted
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Change in Anti-diabetes Medications
时间窗: Baseline to 52 weeks
Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."
次要结局
- Total Weight Change (kg) at Week 52 Compared to Baseline Weight(Baseline to 52 weeks)
研究者
研究点 (2)
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