ISRCTN76193287进行中(未招募)4 期
A Study of Cardiovascular Events iN Diabetes Plus (ASCEND PLUS)
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 入组人数
- 20,000
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
- 性别
- All
入选标准
- •1. Adults aged at least 55 years
- •2. Type 2 diabetes mellitus
排除标准
- •1. Myocardial Infarction
- •3. Current or planned treatment with a GLP-1 RA
- •4. Previous hypersensitivity to or intolerance of GLP-1 RA therapy
- •5. Severe hypoglycaemia within the last six months or during run-in
- •6. Symptomatic hypoglycaemia within the last month
- •7. Currently under consideration to commence insulin
- •8. Severe heart failure (NYHA class 4)
- •9. Current or planned renal replacement therapy
- •10. Unwilling to complete regular follow-up assessments
- •11. Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years
- •12. Type 1 or other type of diabetes (e.g. MODY)
- •13. History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •14. Currently breastfeeding or pregnant, or planning a pregnancy
- •15. Any serious illness which is likely to limit survival or active participation for at least 5 years
- •16. Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes
- •17. For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial
- •18. Non-adherence to run-in treatment (i.e. reports taking the run-in tablets ‘Never’ or ‘Only occasionally’
- •19. Their doctor does not wish them to be randomised
研究者
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