EUCTR2021-002806-29-SK进行中（未招募）1 期
A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo and Once-Weekly Dulaglutide in Participants with Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria
- •Have been diagnosed with Type 2 Diabetes
- •Have a stable body weight for the 3 months prior to randomization
- •Male contraception use should be highly effective/effective methods of contraception
- •Women not of childbearing potential (WNOCBP) may participate in this trial
- •Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 296
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •Exclusion Criteria
- •Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
- •Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
- •Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
- •Have acute or chronic pancreatitis
- •Have obesity induced other endocrine disorders (Cushing’s syndrome or Prader - Willi syndrome
- •Have gastric emptying abnormality or chronically take medications impacting GI motility
- •Have poorly controlled hypertension
- •Have the following heart conditions: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
- •Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
- •Have HIV, or Hepatitis B or Hepatitis C
研究者
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