JPRN-jRCTs031200437已完成未知
Study of OmarigliptiN, Weekly DPP-4 inhibitor, to evaluate the effect on psychological Attitudes and Responses compared with Daily DPP-4 inhibitors in patients with type 2 diabetes mellitus - ONWARD-DPP4 study
Akai Hiroaki0 个研究点目标入组 216 人开始时间: 2021年3月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 216
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 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included in this study:
- •1.Patients with type 2 diabetes mellitus who use once daily or twice daily DPP-4 inhibitor.
- •2.Patients who do not change the anti-diabetic agents (dose, usage, or type) within 8 weeks before giving their consent.
- •3.Male or female aged 20 years or older at giving their consent.
- •4.Patients who provide their consent in a written form by themselves.
排除标准
- •Patients who fall into any of the following criteria are excluded from participating in the study:
- •1.Patients who use any combination tablets with DPP-4 inhibitor.
- •2.Patients who have history of use of omarigliptin or trelagliptin.
- •3.Patients who use 10 or more pharmaceutical agents.
- •4.Patients whose HbA1c is 10% or higher at giving their consent.
- •5.Patients who have history of severe hypoglycemia within a year before giving their consent.
- •6.Patients with type 1 diabetes mellitus or secondary diabetes.
- •7.Patients who routinely use any infusions such as insulin or GLP-1 receptor agonist.
- •8.Patients with cognitive dysfunction or psychiatric disease.
- •9.Patients with alcoholism or drug addiction
- •10.Patients in the perioperative period, or with serious infection or injury.
- •11.Patients with atrial fibrillation or frequent premature ventricular contraction.
- •12.Patients with moderate-to-severe heart failure (class 3 or worse based on the New York Heart Association (NYHA) Functional Classification).
- •13.Patients with moderate-to-severe renal function (male: serum creatinine > 1.4 mg/dL, female: serum creatinine > 1.2 mg/dL).
- •14.Patients with ascitic fluid or severe hepatic function (AST >= 100 IU/L).
- •15.Patients with history of poorly-controlled hypertension or dyslipidemia within 12 weeks before giving their consent.
- •16.Patients with contraindicated condition to use the study agents.
- •17.Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
- •18.Patients who need legal representative for giving consent.
- •19.Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study
研究者
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