NL-OMON34550已完成3 期
EADER: Liraglutide Effect and Action in Diabetes Evaluation of cardiovascular outcome Results;A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events. - LEADER
ovo Nordisk0 个研究点目标入组 175 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
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
- •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
排除标准
- •1.Type 1 diabetes
- •2. 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
- •3.Use of insulin other than human neutral protamine hagedorn (NPH) insulin or long-acting
- •insulin analogue within 3 months prior to screening. Short-term use of other insulin during this
- •period in connection with intercurrent illness is allowed at Investigator*s discretion
- •4.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
- •5.An acute coronary or cerebrovascular event in the previous 14 days
- •6. Current continuous renal replacement therapy
- •7.End-stage liver disease
- •8.Chronic heart failure NYHA IV
- •9.A prior solid organ transplant or awaiting solid organ transplant
- •10.Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
- •medullary thyroid carcinoma (FMTC)
- •11.Personal history of non-familial medullary thyroid carcinoma
- •12. 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
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