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临床试验/jRCT2031260278
jRCT2031260278招募中不适用

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication. (Eluminate-1)

未提供0 个研究点目标入组 80 人开始时间: 待定
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
  • T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medi
  • HbA1c value of or more 7% to or less 10.5% (53 to 91.3 mmol/mol)
  • Body mass index (BMI) of or more 23 kg/m2 at screening
  • Stable body weight (self-reported or documented) for 90 days prior to screening

排除标准

  • Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
  • Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
  • Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
  • History of acute or chronic pancreatitis
  • Severe congestive heart failure (New York Heart Association IV)
  • History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

研究者

发起方
未提供

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