JPRN-jRCT2051210029已完成1 期
A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Japanese Participants with Type 2 Diabetes Mellitus - J1I-JE-GZBC
Wakayama Naohiko0 个研究点目标入组 66 人开始时间: 2021年5月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
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 <= 70age old（—）
- 性别
- All
入选标准
- •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 lead-in and screening
- •-Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m2), inclusive, and a body weight of at least 54 kilograms (Kg).
- •-Males and females not of childbearing potential
排除标准
- •-Have type 1 diabetes mellitus (T1DM)
- •-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).
研究者
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