A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus (T2DM) for at least 1 year
- •Have received a stable daily dose of basal insulin at screening
- •Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
- •Have a body mass index greater than (>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening
排除标准
- •Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body weight at screening
- •Have received insulins except for basal insulins
- •Have received sulfonylurea at more than half of the maximum approved dose level
- •Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
- •Have had more than 1 episode of severe hypoglycemia within 6 months before entry
研究组 & 干预措施
LY3209590
LY3209590 administered subcutaneously (SC).
干预措施: LY3209590 (Drug)
Insulin Degludec
Insulin degludec administered SC.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 85
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose(Day 1 through Day 85)
- Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590(Predose on Day 1 through Day 85)