NCT01455896已完成3 期
A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
Intarcia Therapeutics3 个研究点 分布在 1 个国家目标入组 4,156 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
- 4,156
- 试验地点
- 3
- 主要终点
- time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),
研究概览
简要总结
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBA1c > 6.5%
- •History of coronary, cerebrovascular or peripheral artery disease
排除标准
- •history of pancreatitis
研究组 & 干预措施
ITCA 650 60 mcg/day
Experimental
ITCA 650 is exenatide in DUROS
干预措施: ITCA 650 (Drug)
ITCA placebo
Other
干预措施: ITCA placebo (Other)
结局指标
主要结局
time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
3 期
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With MetforminT2DMNCT06571591Celltrion582
Unknown
2 期
Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM)Atherosclerotic Cardiovascular DiseaseSubclinical Disease and/or SyndromeNCT01353066Hospital Clinic of Barcelona240
已完成
3 期
A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)Type 2 Diabetes MellitusNCT02791490Merck Sharp & Dohme LLC458
终止
3 期
An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)Obesity Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT00430742Merck Sharp & Dohme LLC600
终止
3 期
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary DiseaseModerate Chronic Obstructive Pulmonary DiseaseType 2 Diabetes MellitusType 1 Diabetes MellitusAsthmaNCT00642616Mannkind Corporation34