A Randomized, Double-blind, Eventdriven,Placebo-controlled, MulticenterStudy of the Effects of Canagliflozin onRenal and Cardiovascular Outcomes inSubjects With Type 2 Diabetes Mellitusand Diabetic Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,700
- 试验地点
- 22
- 主要终点
- Time to the first occurrence of an
研究概览
简要总结
The goal of this study is to assess whether
canagliflozin has a renal and vascular
protective effect in reducing the
progression of renal impairment relative to
placebo in participants with type 2
diabetes mellitus (T2DM), Stage 2 or 3
chronic kidney disease (CKD) and
macroalbuminuria, who are receiving
standard of care including a maximum
tolerated labeled daily dose of an
angiotensin-converting enzyme inhibitor
(ACEi) or angiotensin receptor blocker
(ARB).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects 30 years and older with Type 2 diabetes mellitus with a hemoglobin A1c HbA1c greater than or equal to 6.5 percent and less than or equal to 12 percent with an estimated glomerular filtration rate eGFR of greater than or equal to 30 milliliter mL per minute per 1.73 meter and less than 90 milliliter mL per minute (min)/1.73meter Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization.
- •Must have a urine albumin to creatinine ratio UACR of greater than 300 milligram mg per g and less than or equal to 5000 mg per g.
排除标准
- •History of diabetic ketoacidosis or type 1 diabetes mellitus.
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria.
- •Renal disease that required treatment with immunosuppressive therapy.
- •Known significant liver disease.
- •Current or history of New York Heart Association (NYHA) Class IV heart failure.
- •Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening.
结局指标
主要结局
Time to the first occurrence of an
时间窗: Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ] | endpoint]. The primary composite endpoint of | the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.
event in the primary composite
时间窗: Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ] | endpoint]. The primary composite endpoint of | the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.
endpoint.
时间窗: Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ] | endpoint]. The primary composite endpoint of | the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.
The primary composite endpoint of the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular
时间窗: Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ] | endpoint]. The primary composite endpoint of | the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.
(CV) death.
时间窗: Time to the first occurrence of an event in the primary composite endpoint [ Time Frame: Baseline, up to approximately Month 66 ] | endpoint]. The primary composite endpoint of | the study includes end-stage kidney disease (ESKD), doubling of serum creatinine, renal or cardiovascular (CV) death.
次要结局
- Time to the first occurrence of an(event in the renal composite endpoint. The renal composite endpoint)
- Time to all-cause death. All deaths occurring during the study(from any cause.)