JPRN-jRCTs031210623招募中未知
Durable effect of imeglimin on the glycemic control in patients with type 2 diabetes mellitus: a multicenter, open-label, randomized, controlled trial - DIGNITY Trial
Bouuchi Ryoutarou0 个研究点目标入组 567 人开始时间: 2022年2月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 567
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
- •1) Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent
- •2) Patients being treated with diet and exercise therapy only at the time of eligibility test
- •However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
- •3) Patients whose HbA1c level is between 6.5% and 9.0% as measured at the time of the eligibility test.
- •4) Patients who have given written consent to participate in this study.
排除标准
- •When consent is obtained
- •1)Patients with type 1 diabetes mellitus
- •2)Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
- •3)Patients who have received GLP-1 RA (short-term use of insulin for trauma or educational admission) within 1 year or less
- •4) Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
- •5) Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
- •6) Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
- •7) Patients with severe obesity (BMI 35 kg/m2 or more)
- •8) Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
- •9) Excessive regular drinkers
- •10)Patients with a previous history of lactic acidosis
- •11)Patients with severe cachexia, diabetic coma or precoma
- •12)Patients with severe infections, surgical patients and those with serious injuries
- •13)Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
- •14)Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
- •15)Patients who are participating in a clinical study with other interventions
- •16) Patients to whom a responsible physician/investigator judged inappropriate for participating in the study
- •In case of eligibility testing
- •17) Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73 m2 or less including those undergoing dialysis
- •18) Patients with severe hepatic disorders (Child-Pugh classification Grade C)
研究者
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