NL-OMON45079已完成4 期
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus ('CANVAS-R') - Canagliflozine cardiovasculair outcome trial - renal
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Man or woman with a diagnosis of T2DM with HbA1c level * 7.0% to * 10.5% at screening
- •and be either (1) not currently on AHA therapy or (2) on AHA monotherapy or combination
- •therapy with any approved agent: eg, sulfonylurea, metformin, pioglitazone,
- •alpha-glucosidase inhibitor, GLP-1 analogue, DPP-4 inhibitor, or insulin.;- History or high risk of CV events defined on the basis of either:
- •Age *30 years with documented symptomatic atherosclerotic CV events:
- •including stroke; MI; hospital admission for unstable angina; coronary artery bypass
- •graft; percutaneous coronary intervention (with or without stenting); peripheral
- •revascularization (angioplasty or surgery); symptomatic with documented
- •hemodynamically-significant carotid or peripheral vascular disease; or amputation
- •secondary to vascular disease.
- •2) age * 50 years with 2 or more of the following risk factors determined at the screening
- •visit: duration of T2DM of 10 years or more, systolic blood pressure >140 mmHg
- •(average of 3 readings) recorded at the Screening Visit, while the subject is on at least
- •one blood pressure-lowering treatment, current daily cigarette smoker, documented
- •micro- or macroalbuminuria (see Section 3.2, Study Design Rationale, for definition)
- •within one year of screening, or documented HDL-C of <1 mmol/L (<39 mg/dL) within
- •one year of screening.
- •Note: An overall target ratio of approximately 70%:30% for CV history (first
- •category):risk factors (second category) will be implemented (with a maximum of
- •approximately 40% in the second category). This target is intended to be a global ratio
- •and may vary by region. The proportion of subjects in these categories will be
- •monitored centrally.
- •Note: the term *documented* in the above paragraphs refers to the required information
- •being clearly noted in hospital/clinical records or in physician-referral documents,
- •copies of which should be retained in the subject*s study files.;- Women must be:
- •postmenopausal, defined as
- •o >45 years of age with amenorrhea for at least 18 months, or
- •o >45 years of age with amenorrhea for at least 6 months and less than 18 months
- •and a known serum follicle stimulating hormone (FSH) level >40 IU/L, or
- •o surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion),
- •or otherwise be incapable of pregnancy, or
- •o heterosexually active and practicing a highly effective method of birth control,
- •including hormonal prescription oral contraceptives, contraceptive injections,
- •contraceptive patch, intrauterine device, double-barrier method (eg, condoms,
- •diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner
- •sterilization, consistent with local regulations regarding use of birth control methods for
- •subjects participating in clinical trials, for the duration of their participation in the study,
- •o not heterosexually active.
- •Note: subjects who are not heterosexually active at screening must agree to utilize a
- •highly effective method of birth control if they become heterosexually active during
- •their participation in the study.;- Women of childbearing potential (ie, those subjects who do not meet the postmenopausal
- •definition above, regardless of age) must have a negative urine pregnancy test at baseline
- •(Day 1) and at screening if required by local regulations (Note: a serum pre
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in
- •the study:;Diabetes-Related/Metabolic
- •- History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or diabetes
- •secondary to pancreatitis or pancreatectomy
- •- History of one or more severe hypoglycemic episodes within 6 months before screening
- •Note: a severe hypoglycemic episode is defined as an event that requires the help of another
- •- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •- Ongoing, inadequately controlled thyroid disorder
- •Note: subjects on thyroid hormone replacement therapy must be on a stable dose for at least
- •6 weeks before Day 1.;Renal/Cardiovascular
- •- Renal disease that required treatment with immunosuppressive therapy or a history of
- •chronic dialysis or renal transplant. Note: subjects with a history of treated childhood renal
- •disease, without sequelae, may participate.
- •- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular
- •accident within 3 months before screening, or a planned revascularization procedure, or
- •history of New York Heart Association (NYHA) Class IV cardiac disease (The Criteria
- •Committee of the New York Heart Association).
- •- Known ECG findings within 3 months before screening that would require urgent diagnostic
- •evaluation or intervention (eg, new clinically important arrhythmia or conduction
- •disturbance);Gastrointestinal
- •- Known history of hepatitis B surface antigen or hepatitis C antibody positive (unless known
- •to be associated with documented persistently stable/normal range aspartate
- •aminotransferase [AST] and alanine aminotransferase [ALT] levels), or other clinically
- •active liver disease
- •- Any history of or planned bariatric surgery;Laboratory
- •- eGFR <30 mL/min/1.73m2 at screening visit
- •- ALT levels >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the
- •ULN, unless in the opinion of the investigator and as agreed upon by the sponsor*s medical
- •officer, the findings are consistent with Gilbert*s disease;Other conditions
- •- History of malignancy within 5 years before screening (exceptions: squamous and basal cell
- •carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the
- •opinion of the investigator, with concurrence with the sponsor*s medical monitor, is
- •considered cured with minimal risk of recurrence)
- •- History of human immunodeficiency virus (HIV) antibody positive
- •- Subject has a current clinically important hematological disorder (eg, symptomatic anemia,
- •proliferative bone marrow disorder, thrombocytopenia)
- •- Investigator*s assessment that the subject*s life expectancy is less than 1 year, or any
- •condition that in the opinion of the investigator would make participation not in the best
- •interest of the subject, or could prevent, limit, or confound the protocol-specified safety or
- •efficacy assessments
- •- Major surgery (ie, requiring general anesthesia) within 3 months of the screening visit or any
- •surgery planned during the subject*s expected participation in the study (except minor
- •surgery, ie, outpatient surgery under local anesthesia)
- •- Any condition that, in the opinion of the investigator, would compromise the well-being of
- •the subject or prevent the subject from meeting or p
研究者
相似试验
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 MellitusEUCTR2013-003050-25-GBJanssen-Cilag International NV5,812
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 MellitusEUCTR2013-003050-25-FRJanssen-Cilag International NV5,700
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: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2013-003050-25-ITJanssen-Cilag International NV5,700
进行中（未招募）
1 期
An Efficacy, Safety and Tolerability Study of Canagliflozin in Patientswith Type 2 Diabetes Mellitus With Potential Cardiovascular Risk FactorsType 2 diabetes mellitus and history or high risk cardiovascular diseaseMedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849EUCTR2009-012140-16-DEJanssen-Cilag International NV4,500
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