NCT00943917已完成2 期
Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Intarcia Therapeutics1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Mean Change in HbA1c (Per Protocol)
研究概览
简要总结
The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18-70 years
- •Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
- •On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
- •Fasting plasma glucose < 240 mg/dL at Screening Visit 1
- •HbA1c ≥ 7% and ≤ 10% at Screening Visit 1
排除标准
- •Prior treatment with exenatide
- •Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
- •History of type 1 diabetes and/or history of diabetic ketoacidosis
- •Body mass index ≥ 40 kg/m2;
- •History of organ transplantation
研究组 & 干预措施
ITCA 650 40/40
Experimental
干预措施: ITCA 650 (Other)
ITCA 650 20/60
Experimental
干预措施: ITCA 650 (Other)
Exenatide Injection
Active Comparator
干预措施: Exenatide Injection (Drug)
ITCA 650 20 mcg/day
Experimental
干预措施: ITCA 650 (Other)
ITCA 650 20/20
Experimental
干预措施: ITCA 650 (Other)
Ex Inj/ITCA 650 40
Experimental
干预措施: Ex Inj/ITCA 650 (Other)
Ex Inj/ITCA 650 60
Experimental
干预措施: Ex Inj/ITCA 650 (Other)
ITCA 650 40 mcg/day
Experimental
干预措施: ITCA 650 (Other)
ITCA 650 40/80
Experimental
干预措施: ITCA 650 (Other)
结局指标
主要结局
Mean Change in HbA1c (Per Protocol)
时间窗: Day 0 to Week 48
Mean change in HbA1c through Week 48
Mean Change in HbA1c (ITT)
时间窗: Day 0 to Week 48
Mean change in HbA1c through Week 48
次要结局
未报告次要终点
研究者
研究点 (1)
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