NCT01455857已完成3 期
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes
Intarcia Therapeutics2 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2013年3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
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c between 7.5% - 10%
- •On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
- •BMI between 25 & 45 kg/m2
排除标准
- •taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- •history of pancreatitis
研究组 & 干预措施
ITCA 650 40 mcg/day
Experimental
干预措施: ITCA 650 (Drug)
ITCA 650 60 mcg/day
Experimental
干预措施: ITCA 650 (Drug)
ITCA placebo
Placebo Comparator
干预措施: ITCA placebo (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 39 weeks
39-week Treatment Period
次要结局
未报告次要终点
研究者
研究点 (2)
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