NCT01798264已完成1 期
A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Intarcia Therapeutics2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of Subjects With Study Drug-Related Adverse Events
研究概览
简要总结
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes >6 months
- •stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
排除标准
- •prior treatment with exenatide
- •history of pancreatitis
- •history of medullary thyroid cancer or multiple endocrine neoplasia 2
研究组 & 干预措施
10 mcg./day
Experimental
ITCA 650 (exenatide in DUROS)
干预措施: ITCA 650 (exenatide in DUROS) (Drug)
20 mcg/day
Experimental
ITCA 650 (exenatide in DUROS)
干预措施: ITCA 650 (exenatide in DUROS) (Drug)
40 mcg/day
Experimental
ITCA 650 (exenatide in DUROS)
干预措施: ITCA 650 (exenatide in DUROS) (Drug)
80 mcg/day
Experimental
ITCA 650 (exenatide in DUROS)
干预措施: ITCA 650 (exenatide in DUROS) (Drug)
结局指标
主要结局
Number of Subjects With Study Drug-Related Adverse Events
时间窗: 4 weeks
次要结局
- To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus(4 weeks)
- Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline(4 weeks)
- Change in Weight From Baseline to 4 Weeks(4 weeks)
研究者
研究点 (2)
Loading locations...
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