JPRN-jRCTs051220061进行中（未招募）未知
A multicenter, randomized controlled, parallel-group comparison trial in patients with type 2 diabetes mellitus to evaluate the efficacy of imeglimin on time in range (Paradime-TIR Trial)
Hirota Yushi0 个研究点目标入组 60 人开始时间: 2022年7月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 < 75age old（—）
- 性别
- All
入选标准
- •1) Patients who have been diagnosed with type 2 diabetes at the time of obtaining consent
- •2) Patients who are between 20 and 75 years of age at the time of consent.
- •3) Patients whose HbA1c level measured at the time of eligibility test is between 6.5% and 9.5%.
- •4) Patients with a body mass index (BMI) of 18.5 k g/m2 or higher at the time of the eligibility test.
- •5) Patients who have given written consent to participate in this clinical study.
排除标准
- •1) Patients using insulin, glucagon-like peptide-1 receptor agonist (GLP-1 RA), or two or more oral hypoglycemic agents (including combination products containing two oral hypoglycemic agents)
- •2) Patients with contraindications listed in the package inserts for imeglimine, metformin, and the FreeStyle Libre Pro sensor and reader (contraindications for the FreeStyle Libre Pro sensor and reader: patients with pacemakers or other implantable medical devices)
- •3) Patients with proliferative diabetic retinopathy (except for patients with old proliferative diabetic retinopathy who do not require treatment)
- •4) Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance)
- •5) Patients with a New York Heart Association (NYHA) cardiac function classification of degree III or IV at evaluation within 1 year.
- •6) Patients who are heavy drinkers (daily consumption of 3 or more drinks is recommended)
- •7) Patients with a history of lactic acidosis
- •8) Patients with a history of severe ketosis, diabetic coma or precoma
- •9) Patients who have undergone surgery with general anesthesia within one month
- •10) Patients with severe infection or serious trauma
- •11) Patients with malignant tumors under treatment or within 5 years of completion of treatment
- •12) Patients with severe hepatic dysfunction at the time of eligibility testing (non-compensated cirrhosis or AST/ALT greater than 4 times the upper limit of normal)
- •13) Patients with renal dysfunction at the time of eligibility testing (estimated glomerular filtration rate [eGFR] less than 45 mL/min/1.73m2)
- •14) Patients who have undergone gastrectomy (not including endoscopic mucosal resection)
- •15) Pregnant women, lactating women, and patients who may be or plan to become pregnant
- •16) Patients participating in clinical research involving other interventions.
- •17) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for t his clinical research.
- •Exclusion criteria 12) and 13) shall be at the time of eligibility testing; otherwise, at the time of obtaining consent.
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