NCT01785771终止3 期
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
Intarcia Therapeutics49 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 49
- 主要终点
- Change in HbA1c between Week 39 and Day 0
研究概览
简要总结
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age 18 to 80 years with type 2 diabetes
- •On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
- •HbA1c >10.0% and ≤12.0%
排除标准
- •Prior treatment with any GLP-1 receptor agonist
- •History of hypersensitivity to exenatide or liraglutide
- •FPG >300 mg/dL
- •History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
- •Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- •history of pancreatitis
研究组 & 干预措施
ITCA 650
Experimental
干预措施: ITCA 650 (exenatide in DUROS) (Drug)
结局指标
主要结局
Change in HbA1c between Week 39 and Day 0
时间窗: 39 weeks
次要结局
未报告次要终点
研究者
研究点 (49)
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