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临床试验/JPRN-jRCTs011230006
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

发起方
akamura Akinobu

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