EUCTR2012-002839-28-BG进行中（未招募）1 期
A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes - SUSTAIN™ 6 – Long term outcomes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,260
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
- •- Men and women with type 2 diabetes mellitus.
- •- Age =50 years at screening and clinical evidence of cardiovascular disease or age =60 years at screening and subclinical evidence of cardiovascular disease.
- •- Anti-diabetic drug naïve, or treated with one or two OAD(s), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OAD(s).
- •- 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 1630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1630
排除标准
- •- Type 1 diabetes mellitus.
- •- Use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening.
- •- Use of any DPP-IV inhibitor within 30 days prior to screening.
- •- Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness.
- •- Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening.
- •- History of chronic pancreatitis or idiopathic acute pancreatitis.
- •- Acute coronary or cerebro-vascular event within 90 days prior to randomisation.
- •- Currently planned coronary, carotid or peripheral artery revascularisation.
- •- Chronic heart failure NYHA class IV.
- •- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
- •- Personal history of non-familial medullary thyroid carcinoma.
- •- Screening calcitonin =50 ng/L.
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