jRCT2031210420已完成不适用
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants with Type 2 Diabetes Mellitus (J2A-JE-GZGB)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs)
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 Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Males and females not of childbearing potential
- •Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
- •Have glycated hemoglobin (HbA1c) value >= 7.0% and <= 10.0% for participants treated with diet and exercise or HbA1c >= 6.5% and <= 9.0% for participants who have washed out antidiabetic medications at screening
- •Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.
排除标准
- •Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- •Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- •Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- •Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of > 500 milligram per deciliter (mg/dL).
- •Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3x upper limit of normal (ULN).
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs)
Number of participants with one or more treatment emergent adverse events (TEAEs) considered by the investigator to be related to study drug administration
Number of Participants with Serious Adverse Event(s) (SAEs)
Number of participants with serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration
次要结局
未报告次要终点
研究者
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