EADERLiraglutide Effect and Action in Diabetes:Evaluation of cardiovascular outcome ResultsA Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events - LEADER®

ovo Nordisk A/S0 个研究点目标入组 8,754 人开始时间: 2010年6月8日最近更新: 2015年12月28日

适应症

试验速览

暂无简介。

•Men or women with type 2 diabetes
•Age = 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age = 60 years at screening and other specified risk factors of vascular disease
•HbA1c = 7.0% at screening
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Type 1 diabetes
•Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening
•Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion
•Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months
•An acute coronary or cerebrovascular event in the previous 14 days
•Current continuous renal replacement therapy
•End-stage liver disease
•Chronic heart failure NYHA IV
•A prior solid organ transplant or awaiting solid organ transplant
•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
•medullary thyroid carcinoma (FMTC)
•Personal history of non-familial medullary thyroid carcinoma
•Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen’s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial

发起方