NCT01728116终止不适用
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
Morphic Medical Inc.49 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 325
- 试验地点
- 49
- 主要终点
- Primary Efficacy Endpoint: Improvement in HbA1c
研究概览
简要总结
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes
详细描述
This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females aged ≥ 21 years and ≤ 65 years
- •Diagnosis of Type 2 Diabetes for ≤ 20 years
- •Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)
- •Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD)
- •Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.
- •Subjects willing to comply with study requirements
- •Subjects who have signed an informed consent form
排除标准
- •Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
- •C-peptide < 1.0 ng/mL
- •Triglyceride level > 400 mg/dL
- •Vitamin D deficiency (<20 ng/mL)
- •Male subjects with serum Creatinine >1.5 mg/dl or female subjects with Creatinine >1.4 mg/dL
- •Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
- •Height < 5 feet (152.4 cm)
- •Current alcohol or drug addiction
- •Symptomatic kidney stones or gallstones within 6 months prior to randomization
- •Chronic pancreatitis or acute pancreatitis within 12 months of randomization
- •Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
- •Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
- •Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump Inhibitor (PPI)
- •Thyroid disease unless controlled with medication
- •Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure
- •Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure
- •Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure
- •Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening
- •Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers
- •Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics
- •Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
- •Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner
- •Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization
- •Any condition or major illness that places the subject at undue risk by participating in the study
- •Poor dentition not allowing complete chewing of food
- •Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted)
- •Residing in a location without ready access to study site medical resources
- •Documented weight loss of >10 pounds anytime during the 3 months preceding randomization
- •Positive stool guaiac at time of screening
结局指标
主要结局
Primary Efficacy Endpoint: Improvement in HbA1c
时间窗: Baseline and12 months
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
时间窗: Baseline and 12 Months
Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
次要结局
- Assessment of Total Cholesterol Change at 12 Months Compared to Baseline(Baseline and 12 Months)
- Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months(Baseline and 12 Months)
- Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months(Baseline and 12 Months)
- Triglycerides Change From Baseline(Baseline and 12 Months)
- Diastolic BP Change From Baseline(Baseline and 12 Months)
- LDL Change From Baseline(Baseline and 12 Months)
- Fasting Glucose Change From Baseline(Baseline and 12 Months)
- Systolic BP Change From Baseline(Baseline and 12 Months)
研究者
研究点 (49)
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