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
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