JPRN-jRCTs011230006招募中4 期
Effect of initial treatment with tofogliflozin or metformin on pancreatic beta-cell function in subjects with drug-naive type 2 diabetes -A multicenter, prospective, open-label, parallel-group, randomized, comparative study
akamura Akinobu0 个研究点目标入组 70 人开始时间: 2023年5月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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 < 90age old(—)
- 性别
- All
入选标准
- •1) Age 20-90 years old
- •2) HbA1c 6.5-9.0% and urine ketone negative
- •3) Patients with type 2 diabetes who have not been taking any hypoglycemic agents more than 3 months
- •4) Written informed consent
排除标准
- •1) History of anaphylaxis of tofogliflozin
- •2) History of anaphylaxis of metformin
- •3) History of lactic acidosis
- •4) Unstable retinopathy
- •5) Severe hepatic, renal, or cardiac dysfunction
- •6) Pregnancy or possibly pregnant females
- •7) Severe ketosis, diabetic coma
- •8) Severe infection, surgery, serious trauma
- •9) Deficiency of insulin secretion
- •10) Dehydration or possibly dehydration
- •11) Excessive alcohol consumption
- •12) Malnutrition, starvation, debility, pituitary or adrenal insufficiency
- •13) Inability to consume an appropriate diet
- •14) Incompatibility with the trial for other reasons, as determined by the physician
研究者
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