EUCTR2009-012140-16-DE进行中（未招募）1 期
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus - The CANVAS Trial: CANagliflozin CardioVascular Assessment Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must have a diagnosis of T2DM and a history of or a high risk for CV disease
- •Patients must have inadequate diabetes control (as defined by HbA1c greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs
- •Full details are included within the CANVAS study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1350
排除标准
- •A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening
研究者
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进行中（未招募）
1 期
A study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants with Type 2 Diabetes MellitusPatients with type 2 diabetes mellitus (T2DM) receiving standard of care but with inadequate glycemic control and at elevated risk of cardiovascular (CV) eventsMedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2013-003050-25-NLJanssen-Cilag International NV5,700