JPRN-UMIN000014589已完成4 期
Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus - TOPLEVEL (Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction with Type 2 Diabetes Mellitus)
TOPLEVEL study office0 个研究点目标入组 936 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 936
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
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •- Patients with type 1 diabetes mellitus - Patients with slowly progressive type 1 diabetes mellitus positive for pancreatic islets related autoimmune antibody as GAD antibody or IA-2 antibody or ICA antibody - Patients with diabetes mellitus caused by evident genetic factors - Patients with diabetes mellitus caused by secondary factors as endocrine disease or liver disease - Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome - Patients with any severe infectious diseases or planed any surgical treatments or suffered any severe traumas - Patients with severe liver dysfunction - Patients with hypophyseoprivic or adrenal insufficiency - Patients under malnutrition or starved state or irregular caloric intake or calorie insufficiency or hyposthenia - Patients judged to be unsuitable for the study as they are planning to exercise intensively - Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs - Patients with a prior history of ileus - Patients showing QT prolongation in the electrocardiogram - Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline - Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months - Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve - Patients already treated with Teneligliptin - Patients who have already received DPP-4 inhibitors and are not able to change these drugs - Women with breast-feeding - Pregnant women or patients who have possibilities of pregnancy - Patients expected to live less than 3 years - Patients with any past histories of drug hypersensitivity against Teneligliptin - Patients already involved in any other interventional clinical trials or planned to be involved - Patients judged to be inappropriate for the study by the doctors in charge
研究者
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