KCT0004092尚未招募未知
EffiCacy and Safety of ANagliptin when added to iNsulin and metformin therapy in patients with uncontrolled Type 2 diAbetes; randomized, placebo-controlled, double-blind, multicenter trial (CANNA study)
Kyung Hee University Hosipital at Gangdong0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? Screening (V1) At the age of 19 years or older, type 2 diabetic patients
- •? Body mass index ? 45 kg / m2
- •? patients whose HbA1c was 7.0% or more and 10.0% or less at the time of screening (V1)
- •? Patients who received stable insulin for the previous 8 weeks on the basis of screening (V1) (without any change of insulin type, the total daily dose should be at least 10 U / day and maximum 1 U / kg / Defined as the case where the total average daily dose was adjusted to within ± 10% for 8 weeks).
- •? When taking metformin, patients who were taken without a change of dose for 8 weeks before screening (V1)
- •? Those who have voluntarily agreed in writing to participate in this clinical trial.
排除标准
- •It is the exclusion criterion that it corresponds to taboo administration of "use precautions" in the permission of guardlet tablet, metformin tablet, and insulin.
- •?patients with renal disease or renal insufficiency (GFR <30 mL / min / m2), which can be caused by conditions such as cardiovascular collapse, acute myocardial infarction and sepsis
- •? Patients with congestive heart failure who need medication
- •? Patients with a history of hypersensitivity to the main ingredient (anagliptin) or other ingredients (including acetaminophen)
- •? Patients using DPP-4 inhibitor and other diabetes remedy (SGLT2 inhibitor, thiazolidinedione, GLP-1 receptor agonist, sulphonylating agent, glinidie, alpha glucosidase, etc.) within 8 weeks based on screening point (V1)
- •? diabetic ketoacidosis, diabetic coma or total coma, type 1 diabetes patients
- •? Patients with severe infection, pre- and post-operative, severe trauma
- •? hepatic dysfunction (AST or ALT more than three times the upper limit of normal), menopausal color, severe pulmonary dysfunction and other conditions that are likely to entail hypoxemia, excessive alcohol consumption, gastrointestinal disorders such as dehydration, diarrhea and vomiting patient
- •? Women who are pregnant or who may be pregnant, nursing mothers
- •? Patient with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
- •? patients with postmenopausal or severe pulmonary dysfunction
- •? Patients with hypersensitivity to insulin or insulin additive
- •? Other patients who were deemed inappropriate by the examiner as subjects
研究者
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