NCT02293720撤回不适用
An Open-Label Extension to Protocol 09-1, Multi-Center, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects
Morphic Medical Inc.0 个研究点开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Mean change in HbA1c value from baseline to 12 months
研究概览
简要总结
A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from study #09-1 who are not treatment failures and have completed 12 months of the study.
详细描述
This is an open-label extension study for subjects who participated in the control arm of study #09-1 (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) who are not treatment failures and completed 12 months of the study.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Control subjects from study # 09-1 who are not treatment failures and have completed 12 months of the study
- •Age ≥21 years and ≤ 65 years
- •Have signed an informed consent form within 30 days of week 52 visit in study #09-
- •HbA1c ≥ 7.5% and ≤ 10%
- •Stable (s) doses (up to 2) of anti -diabetes medication(s) for a minimum of 3 months prior to enrollment with at least one at minimum required dose as outlined below:
- •MET (≥1500 mg/day) OR
- •SU (based on doses specified below) Generic Name (brand name) minimum required dose
- •Glimepiride (Amaryl) 4 (mg/day) Glipizide (Glucotrol) 20 (mg/day) Glipizide (Glucotrol XL) 10 (mg/day) Glyburide (Micronas, Diabeta) 10 (mg/day) Micronized Glyburide (Glynase) 6 (mg/day) Chlorpropamide (Diabinese) 350 (mg/day) Tolazamide (Tolinase 500 (mg/day) Tolbutamide (Orinase) 1500 (mg/day) OR
- •DPP-4i (based on doses specified below) Generic Name (brand name) minimum required dose Sitagliptin (Januvia®) 50 (mg/day) Saxagliptin (Onglyza®) 2.5 (mg/day) Linagliptin (Tradjenta ®) 5 (mg/day) Alogliptin (Nesina®) 12.5 (mg/day)
- •TZD (based on doses specified below) Generic Name (brand name) minimum required dose Rosiglitazone (Avandia®) 4 (mg/day) Pioglitazone (Actos®) 30 (mg/day)
- •BMI ≥ 30 and ≤ 55
- •Willing to comply with study requirements
- •Documented negative pregnancy test in women of childbearing potential
- •Women of childbearing potential not intending to become pregnant for the duration of their trial participation
排除标准
- •Any change from the subject's previous health status from assessment for eligibility in pivotal trial phase (such as a new condition or major illness) that places the subject at undue risk by participating in the study
- •C-peptide < 1.0 ng/mL
- •Triglyceride level > 400 mg/dL
- •Vitamin D deficiency (<20ng/ml)
- •Male subjects with serum Cr >1.5 mg/dl or female subjects with Cr >1.4 mg/dl
- •Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
- •Symptomatic kidney stones or gallstones within 6 months prior to baseline (within 30 days of week 52 visit from #09-1 study)
- •Acute pancreatitis at the time of baseline (within 30 days of week 52 visit from #09-1 study)
- •Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
- •Currently taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g. aspirin, ibuprofen, etc.) within 10 days of the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
- •Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
- •Currently taking the following medications (at the time of enrollment) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:
- •Restricted Medications/Supplements Systemic corticosteroids Drugs known to affect GI motility (e.g. Reglan) Prescription or over-the-counter weight loss medication(s) Medications known to cause significant weight gain (refer to study reference manual (SRM) or weight loss (e.g. chemotherapeutics)
- •Currently taking ≥ two of the following medications for type 2 diabetes; MET, SU, DDP-4i and TZD at baseline (within 30 days of week 52 visit from #09-1 study)
- •Currently taking medications for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g. GLP1 or insulin) at baseline (within 30 days of week 52 visit from #09-1 study)
- •Chronic use of narcotics, opiates, or benzodiazepines and other addictive tranquilizers
- •Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- •Active H. pylori (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
- •Residing in a location without ready access to study site medical resources
- •Documented weight loss of > 10 pounds anytime during the 3 months prior to enrollment
结局指标
主要结局
Mean change in HbA1c value from baseline to 12 months
时间窗: 52 weeks
Changes in HbA1c from baseline to 12 month
Measure the incidence of device related serious adverse events requiring an early removal
时间窗: 52 weeks
Demonstrated to be less than or equal to 15%
次要结局
未报告次要终点
研究者
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