JPRN-jRCTs051220028进行中（未招募）未知
Investigation of the Mechanism of Action of imeglimin in Japanese Patients with Type 2 Diabetes-delineation of the profile of imeglimins mechanism using glucose clamp test
Sakaguchi Kazuhiko0 个研究点目标入组 30 人开始时间: 2022年5月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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 between 20 and 75 years old
- •(2)Patients diagnosed with type 2 diabetes mellitus
- •(3)BMI of the patients more than 18.5 kg/m2
- •(4)Patients who have been taking only diet and ex ercise therapy or only dipeptidyl peptidase 4 (DPP 4) inhibitors without changing the dosage and ad ministration for the treatment of diabetes for at least 8 weeks prior to obtaining consent
- •(5)Patients whose HbA1c is less than 9.5 % at the time of eligibility test
- •(6)Patients who have given their free and written consent to participate in this clinical research
排除标准
- •(1)Patients using insulin, GLP-1RA, or oral hypoglycemic agents other than DPP4 inhibitors
- •(2)Patients with severe hepatic dysfunction (AST/ALT greater than 4 times the upper limit of normal)
- •(3)Patients with renal dysfunction (eGFR less than 45 mL/min/1.73m2)
- •(4)Patients who have undergone gastrectomy (not including endoscopic mucosal resection)
- •(5)Patients with proliferative diabetic retinopathy ( except for patients with obsolete proliferative diabetic retinopathy that does not require treatment)
- •(6)Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance)
- •(7)Patients with a cardiac function classification of grade 3 or 4 according to NYHA at an evaluation within the last year
- •(8)Patients who drink excessively and habitually
- •(9)Patients with a history of lactic acidosis
- •(10)Patients with a history of severe ketosis, diabetic coma, or precoma
- •(11)Patients who have undergone major surgery within one month
- •(12)Patients with severe infection or serious trauma
- •(13)Patients with malignant tumors under treatment or within 5 years of completion of treatment
- •(14)Pregnant women, lactating women, and patients who may be or are planning to become pregnant
- •(15)Patients who have used antibiotics or antiparasitic drugs within one month prior to eligibility confirmation
- •(16)Patients who have taken PPI (proton pump inhibitor), steroids, or immunosuppressive drugs within one month prior to eligibility confirmation
- •(17)Patients with lower gastrointestinal diseases ( Crohn's disease, ulcerative colitis, short bowel syndrome, celiac disease, etc.)
- •(18)Patients who are participating in clinical research involving other interventions(However, participation in the Study to evaluate intestinal FDG accumulation on 18F-FDG-PET/MRI in patients taking imegurimine or metformin is acceptable)
- •(19)Patients who are judged by the principal investigator or sub-investigator to be inappropriate for this clinical research
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