JPRN-jRCTs051180136进行中（未招募）4 期
Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus - TOPLEVEL study
Kitakaze Masafumi0 个研究点目标入组 936 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 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
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1) Asian aged from 20 to 85 years old at baseline
- •2) Patients with type 2 diabetes mellitus and including either a) or b) criteria
- •a) Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s)
- •b) Patients possible to change the anti-diabetic agent(s)
- •3) Patients with left ventricular ejection fraction more than 40%
- •4) Patients with written informed consent
排除标准
- •1) Patients with type 1 diabetes mellitus
- •2) 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
- •3) Patients with diabetes mellitus caused by evident genetic factors
- •4) Patients with diabetes mellitus caused by secondary factors as endocrine disease or liver disease
- •5) Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
- •6) Patients with any severe infectious diseases or planed any surgical treatments or suffered any severe traumas
- •7) Patients with severe liver dysfunction
- •8) Patients with hypophyseoprivic or adrenal insufficiency
- •9) Patients under malnutrition or starved state or irregular caloric intake or calorie insufficiency or hyposthenia
- •10) Patients judged to be unsuitable for the study as they are planning to exercise intensively
- •11) Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs
- •12) Patients with a prior history of ileus
- •13)Patients showing QT prolongation in the electrocardiogram
- •14) Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline
- •15) Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months
- •16) Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve
- •17) Patients already treated with Teneligliptin
- •18) Patients who have already received DPP-4 inhibitors and are not able to change these drug
- •19) Women with breast-feeding
- •20) Pregnant women or patients who have possibilities of pregnancy
- •21) Patients expected to live less than 3 years
- •22)Patients with any past histories of drug hypersensitivity against Teneligliptin
- •23) Patients already involved in any other interventional clinical trials or planned to be involved
- •24) Patients judged to be inappropriate for the study by the doctors in charge
研究者
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