CTRI/2018/02/011714Other3 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 (SUSTAINâ?¢ 6 â?? Long term outcomes)
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
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
入选标准
- •1. Men and women with type 2 diabetes mellitus
- •2. Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease
- •3.Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs
- •4. HbA1c above or equal to 7.0% at screening
排除标准
- •1. 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
- •2. History of chronic pancreatitis or idiopathic acute pancreatitis
- •3. An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2 (week 0)
- •4. Currently planned coronary, carotid or peripheral artery revascularisation
- •5. Chronic heart failure New York Heart Association (NYHA) class IV
- •6. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
- •7. Personal history of non-familial medullary thyroid carcinoma
- •8. Screening calcitonin above or equal to 50 ng/L
- •9. Type 1 diabetes mellitus
- •10. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
- •11. Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening
- •12. 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
研究者
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