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临床试验/JPRN-jRCT2080224025
JPRN-jRCT2080224025已完成2 期

A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise

AstraZeneca KK0 个研究点目标入组 60 人开始时间: 2018年8月27日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
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 ot applicable(—)
性别
All

入选标准

  • Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening
  • - Individuals who are diagnosed with T2DM
  • - Individuals whose current condition at enrolment (Visit 1) is drug naive
  • - BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

排除标准

  • - Subjects with any of the following results at screening:
  • Aspartate transaminase (AST) 2.5 X upper limit of normal (ULN) or more
  • Alanine transaminase (ALT) 2.5 X ULN or more
  • Total bilirubin (TBL) 2 X ULN or more
  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) 60 mL/minute/1.73 m2 or less at screening
  • - Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

研究者

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